510(k) K011337 ยท JOZ System, Automated Platelet Aggregation
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
| Applicant | Accumetrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 16, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2014 | Accumetrics Inc VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit.
Product Usage:
The VerifyNow System is a turbidimetric based optical detection system which measures plate Terminated |
JOZ | None listed |
| Dec 11, 2013 | Accumetrics Inc VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310,
10 tests/box; 690 total tests.
The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycopr Terminated |
JOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.