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 K192524. Device: Lumipulse G CA15-3. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2020-09-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192730. Device: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV. Applicant as listed: Biosystems S.A.. Decision date: 2020-09-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201551. Device: KetoSens BT Blood B-Ketone Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2020-09-09.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K200027. Device: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter. Applicant as listed: Jiangsu Caina Medical Co.,Ltd. Decision date: 2020-09-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193340. Device: GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System. Applicant as listed: Microtech Medical, Inc.. Decision date: 2020-09-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201570. Device: PF4 Enhanced assay. Applicant as listed: Immucor Gti Diagnostics, Inc.. Decision date: 2020-09-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200530. Device: AMICUS Separator System. Applicant as listed: Fresenius Kabi AG. Decision date: 2020-09-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192665. Device: Accelerate Pheno System, Accelerate PhenoTest BC Kit. Applicant as listed: Accelerate Diagnostics, Inc.. Decision date: 2020-09-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193115. Device: EUROIMMUN Anti-BP230-CF ELISA (IgG). Applicant as listed: Euroimmun Us, Inc.. Decision date: 2020-09-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201494. Device: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card. Applicant as listed: Advin Biotech, Inc.. Decision date: 2020-09-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201849. Device: eNAT molecular collection and preservation medium. Applicant as listed: Copan Italia Spa. Decision date: 2020-09-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202007. Device: LZI Oxycodone III Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2020-09-17.
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.