510(k) K141427 ยท JOZ System, Automated Platelet Aggregation
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
| Applicant | Accumetrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 24, 2015 |
| Received | May 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | Accriva Diagnostics, Inc. VerifyNow PRUTest Platelet Reactivity Test REF 85225
UDI-DI code: 10711234150078
The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of pl Open, Classified |
JOZ | None listed |
| Mar 30, 2022 | Accriva Diagnostics, Inc. The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, in Terminated |
JOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.