510(k) K973100 ยท JIT Calibrator, Secondary
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
| Applicant | Dade Chemistry Systems, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 29, 1997 |
| Received | Aug 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973100
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.