510(k) K821669 ยท DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
AMES TDA GENTAMICIN TEST
| Applicant | Miles Laboratories, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 15, 1982 |
| Received | Jun 7, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821669
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.