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 K210127. Device: iQ200 System, iChemVELOCITY Automated Urine Chemistry System. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2021-07-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200256. Device: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2021-07-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193490. Device: SensiTox C. difficile Toxin Test. Applicant as listed: First Light Diagnostics, Inc.. Decision date: 2021-07-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203562. Device: Finetest Lite Blood Glucose Monitoring System. Applicant as listed: Osang Healthcare Co. , Ltd.. Decision date: 2021-07-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200210. Device: ADVIA Centaur® Total hCG assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2021-07-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202067. Device: EliA SmDP-S. Applicant as listed: Phadia AB. Decision date: 2021-07-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202304. Device: NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets). Applicant as listed: Nyu Langone Medical Center. Decision date: 2021-07-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193397. Device: ADVIA Centaur® Digoxin assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2021-07-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211302. Device: Elecsys Syphilis. Applicant as listed: Roche Diagnostics. Decision date: 2021-07-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201009. Device: CHIRAVAC Blood Collection Needles. Applicant as listed: Chirana T. Injecta. Decision date: 2021-07-21.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K202612. Device: Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL). Applicant as listed: Thermo Fisher Scientific. Decision date: 2021-07-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200129. Device: OncoMate MSI Dx Analysis System. Applicant as listed: Promega Corporation. Decision date: 2021-07-26.
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.