510(k) K800537 ยท DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
GAMMA STICK GENTAMICIN RIA KIT
| Applicant | Alpha Gamma Laboratory, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 24, 1980 |
| Received | Mar 10, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800537
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.