510(k) K864945 ยท JFH Acid Phosphatase (Prostatic), Tartrate Inhibited
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 5, 1987 |
| Received | Dec 17, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864945
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.