ACCESS THYROGLOBULIN ANITBODY— 510(k) K112933
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K112933 for ACCESS THYROGLOBULIN ANITBODY, Substantially Equivalent on 2011-12-27. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JNL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chaska, MN, US
Recent devices under product code JNL
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K112933
K-number listed on FDA's recall record- Z-0265-2025 — Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
- Z-2242-2020 — Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112933.
Data sourced from openFDA. This site is unofficial and independent of the FDA.