510(k) K853048 ยท DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
| Applicant | Photec Diagnostics, Inc., Little Falls NJ, US |
| Decision | Substantially Equivalent, Aug 28, 1985 |
| Received | Jul 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853048
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.