510(k) K953926 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
| Applicant | International Enzymes, Inc., San Marcos CA, US |
| Decision | Substantially Equivalent, Sep 15, 1995 |
| Received | Aug 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953926
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.