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 K193650. Device: LIAISON Ferritin. Applicant as listed: DiaSorin, Inc.. Decision date: 2021-09-14.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202885. Device: GlucoSure HT Plus Blood Glucose Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2021-09-15.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210440. Device: Disposable Sampler Inactivated Transport Media, Nest ITM. Applicant as listed: Wuxi Nest Biotechnology Co., Ltd.. Decision date: 2021-09-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201441. Device: Elecsys Troponin T Gen 5. Applicant as listed: Roche Diagnostics. Decision date: 2021-09-21.
Source: api.fda.gov · Retrieved 2026-10-30
FDA 510(k) index record K200898. Device: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin. Applicant as listed: Medicon Hellas S.A. Decision date: 2021-09-21.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212727. Device: FilmArray Pneumonia Panel. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2021-09-22.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211667. Device: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). Applicant as listed: Changzhou Universal Medical Equipment Co., Ltd.. Decision date: 2021-09-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211973. Device: DRI Cocaine Metabolite Assay. Applicant as listed: Microgenics Corporation. Decision date: 2021-09-24.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210561. Device: Advisor Pro Platform. Applicant as listed: DreaMed Diabetes, Ltd.. Decision date: 2021-09-28.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191288. Device: Acuitas AMR Gene Panel. Applicant as listed: Opgen, Inc.. Decision date: 2021-09-30.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201312. Device: VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2021-10-04.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201394. Device: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2021-10-05.
Source: api.fda.gov · Retrieved 2026-10-30
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.