Accumetrics Inc
FDA Regulatory Profile
Accumetrics Inc appears in FDA public data with 4 recalls, 7 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1172-2014, Class II) was initiated on February 13, 2014. Its most recent 510(k) clearance was granted on July 24, 2015.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1172-2014 | Class II | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Produ | February 13, 2014 |
| Z-0482-2014 | Class II | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The Ve | November 14, 2013 |
| Z-1854-2012 | Class II | VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole bloo | February 6, 2012 |
| Z-1853-2012 | Class II | VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 | February 6, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | July 24, 2015 |
| K051231 | VERIFYNOW-P2Y12 ASSAY | August 5, 2005 |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | October 6, 2004 |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | June 12, 2002 |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | May 16, 2002 |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | October 16, 2001 |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE | December 20, 1999 |