510(k) K012701 ยท JOZ System, Automated Platelet Aggregation
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
| Applicant | Accumetrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 12, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Accumetrics Inc VerifyNow Asprin Assay Kit
Part No. 85034 Terminated |
JOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.