510(k) K834054 ยท JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
DART GAMMA-GT REAGENT SYSTEM
| Applicant | Coulter Electronics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 4, 1984 |
| Received | Nov 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834054
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.