ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER— 510(k) K002905
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K002905 for ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER, Substantially Equivalent on 2000-10-19. 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
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MSW
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K002905
K-number listed on FDA's recall record- 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 K002905.
Data sourced from openFDA. This site is unofficial and independent of the FDA.