510(k) K983553 ยท JZO System, Test, Thyroid Autoantibody
ANTI-TG IGG ELISA TEST SYSTEM
| Applicant | Columbia Bioscience, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 7, 1998 |
| Received | Oct 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983553
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.