510(k) K984228 ยท JZO System, Test, Thyroid Autoantibody
IS ANTI-TPO IGG ELISA TEST SYSTEM
| Applicant | Columbia Bioscience, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Feb 2, 1999 |
| Received | Nov 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.