510(k) K051231 ยท JOZ System, Automated Platelet Aggregation
VERIFYNOW-P2Y12 ASSAY
| Applicant | Accumetrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 5, 2005 |
| Received | May 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2012 | Accumetrics Inc VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots.
Product Usage:
The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the leve Terminated |
JOZ | None listed |
| Jun 21, 2012 | Accumetrics Inc VerifyNow System, part #85005-6H
Product Usage:
The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor Terminated |
JOZ | None listed |
| Dec 6, 2006 | Accumetrics Inc VerifyNow P2Y12 Assay Device Kit, Part Number 85054 Terminated |
JOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.