510(k) K850319 ยท JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 12, 1985 |
| Received | Jan 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850319
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.