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 K220178. Device: Total Immunoglobulin E (IgE). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2022-03-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213887. Device: GAL-1A Plus Blood Glucose Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2022-03-29.
Source: api.fda.gov · Retrieved 2026-10-30
FDA 510(k) index record K213808. Device: Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream. Applicant as listed: Co-Innovation Biotech Co., Ltd.. Decision date: 2022-04-05.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202534. Device: MTM301 Blood Glucose and Ketone Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2022-04-06.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K214023. Device: VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL). Applicant as listed: bioMerieux, Inc.. Decision date: 2022-04-14.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192931. Device: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control. Applicant as listed: Helena Laboratories, Corp.. Decision date: 2022-04-19.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213236. Device: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel. Applicant as listed: Genmark Diagnostics, Incorporated. Decision date: 2022-04-27.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201956. Device: Zeus IFA ANA HEp-2 Test System, Zeus dIFine. Applicant as listed: Zeus Scientific, Inc.. Decision date: 2022-04-29.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220013. Device: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application. Applicant as listed: Scopio Labs , Ltd.. Decision date: 2022-05-03.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211707. Device: BioTeke Sterile Disposable Virus Sampling Kit. Applicant as listed: Bioteke Corporation (Wuxi) Co., Ltd.. Decision date: 2022-05-04.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220685. Device: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx. Applicant as listed: Qingdao Hightop Biotech Co., Ltd.. Decision date: 2022-05-05.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203711. Device: IWL2020 Blood Glucose Monitoring System. Applicant as listed: Roche Diabetes Care, Inc.. Decision date: 2022-05-06.
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.