510(k) K062516 ยท JNL Immunochemical, Thyroglobulin Autoantibody
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 5, 2006 |
| Received | Aug 28, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2011 | Beckman Coulter Inc. Access Thyroglobulin Antibody II, Part Number: A32898
The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human se Terminated |
JNL | None listed |
| Sep 2, 2010 | Beckman Coulter Inc. Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin an Terminated |
JNL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.