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 K202567. Device: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2020-09-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202446. Device: BD Preset Syringe & BD A-Line Syringe. Applicant as listed: Becton, Dickinson and Company. Decision date: 2020-09-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201814. Device: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit. Applicant as listed: Becton, Dickinson and Company. Decision date: 2020-09-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200475. Device: IDS-iSYS Ostase BAP. Applicant as listed: Immunodiagnostic Systems , Ltd.. Decision date: 2020-09-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200544. Device: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+. Applicant as listed: Diamond Diagnostics, Inc.. Decision date: 2020-10-01.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201301. Device: X100 with Full Field Peripheral Blood Smear (PBS) Application. Applicant as listed: Scopio Labs , Ltd.. Decision date: 2020-10-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201908. Device: LIAISON Testosterone xt. Applicant as listed: DiaSorin, Inc.. Decision date: 2020-10-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200595. Device: CellaVision DC-1, CellaVision DC-1 PPA. Applicant as listed: CellaVision AB. Decision date: 2020-10-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201396. Device: Finetest Lite Smart Blood Glucose Monitoring System. Applicant as listed: Osang Healthcare Co. , Ltd.. Decision date: 2020-10-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201438. Device: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer. Applicant as listed: Arlington Scientific, Inc. (Asi). Decision date: 2020-10-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193556. Device: Cryocheck Hex LA. Applicant as listed: Precision Biologic. Decision date: 2020-10-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202089. Device: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer. Applicant as listed: Bonraybio Co., Ltd.. Decision date: 2020-10-28.
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.