510(k) K854875 ยท DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1
| Applicant | Photec Diagnostics, Inc., Little Falls NJ, US |
| Decision | Substantially Equivalent, Jan 24, 1986 |
| Received | Dec 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854875
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.