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 K252684. Device: Labcorp Fentanyl Urine Visual Test. Applicant as listed: Medtox Diagnostics, Inc.. Decision date: 2026-01-29.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253318. Device: Clungene RSV Antigen Rapid Test. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2026-01-30.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253737. Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc.. Decision date: 2026-02-03.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243348. Device: Athelas Home. Applicant as listed: Athelas, Inc.. Decision date: 2026-02-06.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243979. Device: Aptiva APS IgA Reagent. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2026-02-06.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251543. Device: Atellica® IM TSH3-Ultra II (TSH3ULII). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2026-02-06.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252523. Device: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2026-02-12.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253491. Device: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions. Applicant as listed: Roche Diagnostics. Decision date: 2026-02-12.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253490. Device: Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions. Applicant as listed: Roche Diagnostics. Decision date: 2026-02-12.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251742. Device: VELO Respiratory Test. Applicant as listed: Lex Diagnostics Limited. Decision date: 2026-02-13.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253539. Device: Alere NT-proBNP for Alinity i. Applicant as listed: Axis-Shield Diagnostics, Ltd.. Decision date: 2026-02-18.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253687. Device: Access anti-HBc Total. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2026-02-19.
Source: api.fda.gov · Retrieved 2026-10-22
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.