510(k) K813102 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
POLI-MAK II
| Applicant | Pm America, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 24, 1981 |
| Received | Nov 3, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813102
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.