510(k) K772116 ยท DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
AMINOGLYCOSIDE TEST SYSTEM
| Applicant | Nichols Institute Diagnostics, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 28, 1978 |
| Received | Nov 7, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K772116
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.