510(k) K012723 ยท JOZ System, Automated Platelet Aggregation
PLATELETWORKS
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Aug 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012723
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.