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 K242545. Device: RadiForce MX317W-PA. Applicant as listed: Eizo Corporation. Decision date: 2025-05-23.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242820. Device: Puritan PurSafe Plus Collection and Transport System. Applicant as listed: Puritan Medical Products, LLC. Decision date: 2025-05-27.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242830. Device: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer. Applicant as listed: Bonraybio Co., Ltd.. Decision date: 2025-05-30.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241313. Device: OHC COVID-19 Antigen Self Test. Applicant as listed: Osang, LLC. Decision date: 2025-05-30.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250965. Device: Automated Blood Coagulation Analyzer CN-Series (CN-6000). Applicant as listed: Sysmex America, Inc.. Decision date: 2025-06-02.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243499. Device: NG-Test® CTX-M MULTI. Applicant as listed: Ng Biotech. Decision date: 2025-06-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250961. Device: Blood collection tube holders. Applicant as listed: Promisemed Hangzhou Meditech Co., Ltd.. Decision date: 2025-06-04.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243490. Device: LIAISON PLEX Gram-Positive Blood Culture Assay. Applicant as listed: Luminex Corporation. Decision date: 2025-06-06.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250856. Device: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL). Applicant as listed: Biomérieux. Decision date: 2025-06-12.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242872. Device: iDart Lyme IgM ImmunoBlot Kit. Applicant as listed: Id-Fish Technology, Inc.. Decision date: 2025-06-12.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250789. Device: Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.). Decision date: 2025-06-12.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250273. Device: BinaxNOW COVID-19 Ag Card. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2025-06-13.
Source: api.fda.gov · Retrieved 2026-10-23
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.