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 K200009. Device: Adaptive Biotechnologies clonoSEQ Assay. Applicant as listed: Adaptive Biotechnologies Corporation. Decision date: 2020-08-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201938. Device: LZI Fentanyl II Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2020-08-07.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191296. Device: Pointe Scientific Creatinine Kinase (CK) Reagent Set. Applicant as listed: Medtest DX. Decision date: 2020-08-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200133. Device: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2020-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192947. Device: AncestryDNA Saliva Collection Kit. Applicant as listed: Ancestry Genomics, Inc.. Decision date: 2020-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192944. Device: AncestryDNA Factor V Leiden Genetic Health Risk Test. Applicant as listed: Ancestry Genomics, Inc.. Decision date: 2020-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193318. Device: Distinct® Early Detection Pregnancy Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2020-08-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201505. Device: Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2020-08-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192380. Device: ST AIA-PACK BNP. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2020-08-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201476. Device: DreaMed Advisor Pro. Applicant as listed: DreaMed Diabetes, Ltd.. Decision date: 2020-08-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201405. Device: LabPro Data Management System. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-08-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202215. Device: cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2020-09-02.
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.