510(k) K023860 ยท DDZ Albumin, Fitc, Antigen, Antiserum, Control
MICROALBUMIN REAGENT SET AND CALIBRATORS
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Apr 28, 2003 |
| Received | Nov 20, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023860
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.