510(k) K012208 ยท DDC Thyroglobulin, Antigen, Antiserum, Control
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 7, 2001 |
| Received | Jul 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2007 | Beckman Coulter Inc Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890 Terminated |
DDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.