510(k) K974384 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ELECSYS CALCHECK FOLATE
| Applicant | Boehringer Mannheim Corp., Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 8, 1997 |
| Received | Nov 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974384
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.