510(k) K830240 ยท JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
| Applicant | Emd Chemicals, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 18, 1983 |
| Received | Jan 25, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830240
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.