ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS— 510(k) K031269
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K031269 for ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS, Substantially Equivalent on 2003-05-02. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code MSW
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chaska, MN, US
Recent devices under product code MSW
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K031269
K-number listed on FDA's recall record- Z-2322-2025 — Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Z-0100-2024 — Access Thyroglobulin Calibrators
- Z-2240-2020 — Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
- Z-2636-2017 — Access Thyroglobulin, A34085G, Catalog No. 33860
- Z-2733-2015 — Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031269.
Data sourced from openFDA. This site is unofficial and independent of the FDA.