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 K200277. Device: Livongo Blood Glucose Monitoring System (BG1000). Applicant as listed: Livongo Health, Inc.. Decision date: 2020-06-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192957. Device: VivaChek Blood Glucose and B-Ketone Monitoring System. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2020-06-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200107. Device: epoc Blood Analysis System. Applicant as listed: Epocal, Inc.. Decision date: 2020-06-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200909. Device: Hemo Control (optional Add Pack Hemo Control DM). Applicant as listed: Ekf-Diagnostic GmbH. Decision date: 2020-06-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201311. Device: PF4 IgG assay. Applicant as listed: Immucor Gti Diagnostics, Inc.. Decision date: 2020-06-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192028. Device: Yumizen C1200 CRP. Applicant as listed: HORIBA ABX SAS. Decision date: 2020-06-25.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K200825. Device: NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense. Applicant as listed: Hycor Biomedical. Decision date: 2020-06-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193525. Device: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M. Applicant as listed: HORIBA ABX SAS. Decision date: 2020-06-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201423. Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-06-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193204. Device: Cryocheck Chromogenic Factor VIII. Applicant as listed: Precision Biologic. Decision date: 2020-07-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201442. Device: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers. Applicant as listed: Diatron Group. Decision date: 2020-07-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201217. Device: HemoCue Hb 301 System. Applicant as listed: Hemocue AB. Decision date: 2020-08-04.
Source: api.fda.gov · Retrieved 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.