Company ยท US
Accumetrics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2015. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOZ | System, Automated Platelet Aggregation | 14 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2015 | K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST Accumetrics, Inc. | JOZ |
| Aug 5, 2005 | K051231 | VERIFYNOW-P2Y12 ASSAY Accumetrics, Inc. | JOZ |
| Oct 6, 2004 | K042423 | VERIFYNOW-ASPIRIN ASSAY Accumetrics, Inc. | JOZ |
| Jun 12, 2002 | K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) Accumetrics, Inc. | JOZ |
| May 16, 2002 | K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) Accumetrics, Inc. | JOZ |
| Oct 16, 2001 | K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) Accumetrics, Inc. | JOZ |
| Dec 20, 1999 | K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM Accumetrics, Inc. | JOZ |
Latest recalls
| 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 | 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 |