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 K223722. Device: MIO Blood Glucose Monitoring System. Applicant as listed: Mio Labs, Inc.. Decision date: 2023-06-28.
Source: api.fda.gov · Retrieved 2026-10-28
FDA 510(k) index record K230935. Device: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae). Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-06-30.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230917. Device: FebriDx Bacterial / Non-bacterial Point of Care Assay. Applicant as listed: Lumos Diagnostics, Inc.. Decision date: 2023-06-30.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223854. Device: Unistik® ShieldLock, Unistik VacuFlip. Applicant as listed: Owen Mumford, Ltd.. Decision date: 2023-06-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230944. Device: MeMed BV. Applicant as listed: MeMed Diagnostics, Ltd.. Decision date: 2023-06-30.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221664. Device: CLEARinse CTS Specimen Collection and Transport System. Applicant as listed: Aardvark Medical, Inc.. Decision date: 2023-07-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230901. Device: Premier HpSA Flex (619096). Applicant as listed: Meridian Bioscience, Inc.. Decision date: 2023-07-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231568. Device: HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20). Applicant as listed: Hardy Diagnostics. Decision date: 2023-07-06.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230080. Device: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood. Applicant as listed: Yangzhou Medline Industry, Co., Ltd.. Decision date: 2023-07-07.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230863. Device: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit. Applicant as listed: Zeus Scientific. Decision date: 2023-07-13.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222116. Device: Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-07-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220282. Device: i-STAT PTplus Cartridge with the i-STAT 1 System. Applicant as listed: Abbott Laboratories. Decision date: 2023-07-14.
Source: api.fda.gov · Retrieved 2026-10-28
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.