Accumetrics, Inc.

Medical device manufacturer in San Diego, CA.

7510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestJOZ · Traditional 07/24/2015SE
K051231VERIFYNOW-P2Y12 AssayJOZ · Traditional 08/05/2005SE
K042423Verifynow-Aspirin AssayJOZ · Special 10/06/2004SE
K012701Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)JOZ · Traditional 06/12/2002SE
K013596Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)JOZ · Traditional 05/16/2002SE
K011337Ultegra System Rapid Platelet Function Assay (Rpfa)JOZ · Traditional 10/16/2001SE
K992531Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System…JOZ · Traditional 12/20/1999SE

Recalls

RecallProductInitiated
Z-1172-2014 Class IIVerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test…Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous… 02/13/2014Terminated
Z-0482-2014 Class IIVerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests.…Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the… 11/14/2013Terminated
Z-1854-2012 Class IIVerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a…The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically… 02/06/2012Terminated
Z-1853-2012 Class IIVerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The…The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically… 02/06/2012Terminated
Z-0228-2007 VerifyNow P2Y12 Assay Device Kit, Part Number 85054The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low… 09/05/2006Terminated