510(k) K923509 ยท JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase
GAMMA-GT
| Applicant | Randox Laboratories, Ltd., Antrim, N. Ireland, IR |
| Decision | Substantially Equivalent, Dec 3, 1992 |
| Received | Jul 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923509
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.