510(k) K780323 ยท DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
QUANTITOPE 125-I GENTAMICIN RIA KIT
| Applicant | Kallestad Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 17, 1978 |
| Received | Feb 27, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780323
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.