510(k) K993132 ยท JIT Calibrator, Secondary
GENZYME DIRECT AMYLASE VERIFIER
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Oct 4, 1999 |
| Received | Sep 20, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K993132
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.