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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FDA 510(k) index record K231978. Device: BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2023-08-31.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223597. Device: 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). Applicant as listed: 23AndMe, Inc.. Decision date: 2023-08-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221197. Device: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2023-09-05.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221869. Device: BCR-ABL1 (p210) % IS Kit (Digital PCR Method). Applicant as listed: Suzhou Sniper Medical Technologies Co., Ltd.. Decision date: 2023-09-05.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230890. Device: ISE Electrodes. Applicant as listed: Randox Laboratories, Ltd.. Decision date: 2023-09-08.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222921. Device: Minuteful-kidney test. Applicant as listed: Healthy.Io, Ltd.. Decision date: 2023-09-08.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213510. Device: IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2023-09-08.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223755. Device: i-STAT G cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2023-09-11.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222831. Device: CRYOcheck Factor VIII Deficient Plasma with VWF. Applicant as listed: Precision Biologic, Inc.. Decision date: 2023-09-13.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221640. Device: AlloMap Heart Molecular Expression Testing. Applicant as listed: Caredx, Inc.. Decision date: 2023-09-13.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223857. Device: i-STAT G3+ cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2023-09-15.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231336. Device: T2 Biothreat Panel. Applicant as listed: T2biosystems, Inc.. Decision date: 2023-09-15.
Source: api.fda.gov · Retrieved 2026-10-27
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.