Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241317. Device: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2024-09-30.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210933. Device: YSI 2900C Biochemistry Analyzer. Applicant as listed: Ysi, Inc.. Decision date: 2024-09-30.
Fuente: api.fda.gov · Consultado el 2026-10-19
FDA 510(k) index record K241967. Device: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.. Applicant as listed: Thermo Fisher Scientific. Decision date: 2024-10-01.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242498. Device: Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC. Applicant as listed: Aicheck Biotech, Inc.. Decision date: 2024-10-01.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242613. Device: NxTAG® Respiratory Pathogen Panel. Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2024-10-02.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241869. Device: BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2024-10-04.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240640. Device: Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System. Applicant as listed: Sejoy Biomedical Co., Ltd.. Decision date: 2024-10-08.
Fuente: api.fda.gov · Consultado el 2026-10-19
FDA 510(k) index record K242021. Device: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.. Applicant as listed: Thermo Fisher Scientific. Decision date: 2024-10-09.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240315. Device: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05). Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2024-10-10.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240797. Device: PPH Saliva Collection Kit. Applicant as listed: Permantis Public Health. Decision date: 2024-10-11.
Fuente: api.fda.gov · Consultado el 2026-10-19
FDA 510(k) index record K240242. Device: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold). Applicant as listed: Anhui Deepblue Medical Technology Co., Ltd.. Decision date: 2024-10-11.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232565. Device: UriSponge. Applicant as listed: Copan Italia Spa. Decision date: 2024-10-11.
Fuente: api.fda.gov · Consultado el 2026-10-19
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.