510(k) K973358 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
MYOGLOBIN CONTROL SET
| Applicant | Boehringer Mannheim Corp., Pleasanton CA, US |
| Decision | Substantially Equivalent, Oct 6, 1997 |
| Received | Sep 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973358
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.