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 K193504. Device: HardyDisk AST Cefiderocol 30ug (FDC30). Applicant as listed: Hardy Diagnostics. Decision date: 2020-01-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192859. Device: CareSens S Clear BT Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2020-01-24.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K193051 — LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193051. Device: LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set. Applicant as listed: DiaSorin, Inc.. Decision date: 2020-01-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193480. Device: BIOEASY Multi-Drug Test Cup. Applicant as listed: Shenzhen Bioeasy Biotechnology Co., Ltd.. Decision date: 2020-01-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191832. Device: Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223). Applicant as listed: Kurin, Inc.. Decision date: 2020-02-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193610. Device: BreathID Smart System. Applicant as listed: Exalenz Bioscience , Ltd.. Decision date: 2020-02-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193103. Device: NeoBase 2 Non-derivatized MSMS Kit. Applicant as listed: Perkinelmer, Inc.. Decision date: 2020-02-07.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K200065. Device: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2020-02-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193489. Device: ADVIA Centaur BR. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-02-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191364. Device: T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01. Applicant as listed: Fujimori Kogyo, Co., Ltd.. Decision date: 2020-02-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193475. Device: OneTouch Verio Reflect Blood Glucose Monitoring System. Applicant as listed: Lifescan Europe GmbH. Decision date: 2020-02-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191514. Device: CareStart Flu A&B Plus. Applicant as listed: Access Bio, Inc.. Decision date: 2020-02-18.
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.