510(k) K003534 ยท JPK Mixture, Hematology Quality Control
PENTRA 5D
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 1, 2000 |
| Received | Nov 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003534
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.