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 K212447. Device: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream. Applicant as listed: Hangzhou Sejoy Electronics & Instruments Co., Ltd.. Decision date: 2022-02-18.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220162. Device: Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria. Applicant as listed: Hycor Biomedical. Decision date: 2022-02-18.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202644. Device: Acetaminophen. Applicant as listed: Sekisui Diagnostics P.E.I., Inc.. Decision date: 2022-02-18.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193406. Device: CardioChek Plus Test System; CardioChek Plus Home Test System. Applicant as listed: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. Decision date: 2022-02-26.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210811. Device: Dynamyx Digital Pathology Software. Applicant as listed: Inspirata, Inc.. Decision date: 2022-03-01.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212379. Device: N Latex FLC kappa, N Latex FLC lambda. Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2022-03-02.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213486. Device: GLP systems Track. Applicant as listed: Abbott Laboratories. Decision date: 2022-03-10.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210341. Device: One Step Pregnancy Test. Applicant as listed: Spd Swiss Precision Diagnostics GmbH. Decision date: 2022-03-10.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212461. Device: VITEK MS PRIME. Applicant as listed: bioMerieux, Inc.. Decision date: 2022-03-15.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212623. Device: Healgen Strep A Rapid Test Strip (Throat Swab). Applicant as listed: Healgen Scientific,, LLC. Decision date: 2022-03-16.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203530. Device: Albumin BCP2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-03-18.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210452. Device: Creatinine2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-03-22.
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.