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 K192517. Device: Psychemedics Microplate EIA for Cotinine in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2020-04-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192063. Device: PGDx elio tissue complete. Applicant as listed: Personal Genome Diagnostics. Decision date: 2020-04-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200533. Device: binx io CT/NG Assay and binx io CT/NG System. Applicant as listed: Binx Health, Inc.. Decision date: 2020-04-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200279. Device: ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine. Applicant as listed: Phadia AB. Decision date: 2020-05-01.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192586. Device: LIAISON® Folate. Applicant as listed: DiaSorin, Inc.. Decision date: 2020-05-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200512. Device: ETEST Plazomicin (PLZ) (0.016-256 µg/mL). Applicant as listed: Biomérieux SA. Decision date: 2020-05-07.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200997. Device: Lumipulse G CA19-9-N. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2020-05-14.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K200866 — Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200866. Device: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System). Applicant as listed: Hologic, Inc.. Decision date: 2020-05-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192727. Device: K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2). Applicant as listed: Kamiya Biomedical Company. Decision date: 2020-05-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200509. Device: ADVIA Centaur Vitamin D Total (VitD). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-05-29.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200506. Device: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. Applicant as listed: Chembio Diagnostic Systems. Decision date: 2020-06-03.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201223. Device: LZI Tramadol Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2020-06-04.
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.