510(k) K974825 ยท JIX Calibrator, Multi-Analyte Mixture
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 30, 1998 |
| Received | Dec 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974825
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.