Panels › Hematology › Product code JOZ · Class 2
System, Automated Platelet Aggregation
Regulation 864.5700
0510(k)s in 12 months (38 all time)
1recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in JOZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Accumetrics, Inc. | 7 | 7 |
| Chrono-Log Corp. | 6 | 0 |
| Aggredyne, Inc. | 3 | 1 |
| Helena Laboratories | 4 | 0 |
| Accriva Diagnostics, Inc. | 0 | 3 |
| Bio/Data Corp. | 2 | 0 |
| Dade Behring, Inc. | 2 | 0 |
| Array Medical, Inc. | 1 | 0 |
| Bay Area Hema. Onco. Clinic. & Res. L | 1 | 0 |
| Bellhouse Medical, Inc. | 1 | 0 |
| 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 | K141427 |
| Jan 16, 2025 | Accriva Diagnostics, Inc. VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 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 | K141427 |
| Jul 23, 2019 | Aggredyne, Inc. AggreGuide A-100 Instrument Completed |
JOZ | K122162 K163274 +1 |
| 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 | K011337 K013596 +1 |
| 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 | K011337 K013596 +1 |
| 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 | K051231 |
| 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 | K051231 |
| Dec 6, 2006 | Accumetrics Inc VerifyNow P2Y12 Assay Device Kit, Part Number 85054 Terminated |
JOZ | K051231 |
| Oct 28, 2005 | Accumetrics Inc Accumetrics part number 29001 VerifyNow Instrument, printe power supply Terminated |
JOZ | K992531 |
| Jul 20, 2004 | Accumetrics Inc VerifyNow Asprin Assay Kit
Part No. 85034 Terminated |
JOZ | K012701 |
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