510(k) K901264 ยท JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
COULTER GAMMA-GT (GGT) REAGENT
| Applicant | Coulter Corp., Hialeah FL, US |
| Decision | Substantially Equivalent, Apr 16, 1990 |
| Received | Mar 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901264
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.