510(k) K865053 ยท JZO System, Test, Thyroid Autoantibody
SERA-TEK MICROSOMAL ANTIBODY TEST
| Applicant | Miles Laboratories, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Feb 18, 1987 |
| Received | Dec 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K865053
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.