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 K211675. Device: Dasky Disposable Sampling Tube (Model name: VSM02). Applicant as listed: Ningbo Dasky Life Science Co., Ltd.. Decision date: 2022-08-08.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220900. Device: Safety Blood Collection Needles with/without Needle Holder. Applicant as listed: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Decision date: 2022-08-10.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212361. Device: Novo. Applicant as listed: PathAI, Inc.. Decision date: 2022-08-11.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202739. Device: Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System. Applicant as listed: Bioland Technology, Ltd.. Decision date: 2022-08-12.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220163. Device: Her-2, ER, PR IHControls. Applicant as listed: Boston Cell Standards, Inc.. Decision date: 2022-08-15.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213426. Device: HemosIL ReadiPlasTin. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2022-08-16.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212856. Device: iClean Viral Transport System (VTM-RT kit). Applicant as listed: Huachenyang (Shenzhen) Technology Co. , Ltd.. Decision date: 2022-08-18.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220016. Device: Viramed Borrela All-In-One ViraChip Test Kit. Applicant as listed: Viramed Biotech AG. Decision date: 2022-08-19.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220193. Device: BD MAX Enteric Parasite Panel. Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-08-19.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212140. Device: GlucoSure Link Blood Glucose Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2022-08-25.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220262. Device: Dimension EXL LOCI BRAHMS Procalcitonin (PCT). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2022-08-26.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220799. Device: K-SHIELD Zen. Applicant as listed: Sb-Kawasumi Laboratories, Inc.. Decision date: 2022-08-29.
Source: api.fda.gov · Retrieved 2026-10-29
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.