510(k) K970505 ยท JOZ System, Automated Platelet Aggregation
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 17, 1997 |
| Received | Feb 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970505
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.