510(k) K801295 ยท JFJ Catalytic Methods, Amylase
COBAS REAGENT FOR A-AMYLASE
| Applicant | Roche Analytical Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 8, 1980 |
| Received | Jun 2, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801295
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.