510(k) K972235 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
PRECICONTROL TUMOR MARKER 1 AND 2
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 12, 1997 |
| Received | Jun 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972235
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.