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 K193132. Device: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2019-12-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192220. Device: ReliOn Premier Classic Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2019-12-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193001. Device: Albumin BCP. Applicant as listed: SENTINEL CH. SpA. Decision date: 2019-12-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191967. Device: Unyvero LRT BAL Application. Applicant as listed: Curetis GmbH. Decision date: 2019-12-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191350. Device: ACTIVE® Free Testosterone RIA. Applicant as listed: Immunotech S.R.O.. Decision date: 2019-12-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191147. Device: OC-Auto SENSOR io iFOB Test. Applicant as listed: Eiken Chemical Co., Ltd.. Decision date: 2020-01-02.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K193024. Device: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2020-01-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192920. Device: Oragene®Dx. Applicant as listed: DNA Genotek, Inc.. Decision date: 2020-01-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193493. Device: ADVIA Centaur Total IgE (tIgE). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-01-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193590. Device: CareSens S Fit BT Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2020-01-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192547. Device: MAGLUMI 2000 HCG/ß-HCG. Applicant as listed: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Decision date: 2020-01-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193569. Device: PIVO(TM). Applicant as listed: Velano Vascular. Decision date: 2020-01-21.
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.