510(k) K970458 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS CALCHECK PSA
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Feb 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970458
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.