510(k) K973157 ยท JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | Aug 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973157
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.