Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System Rpfa-Trap Level One Qc, Ultegra System

510(k) K992531

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK992531	Date20 Dec 1999Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1172-2014 FDA Class II initiated 13 Feb 2014
Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.
- Terminated Z-0482-2014 FDA Class II initiated 14 Nov 2013
Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
- Terminated Z-0102-06 FDA Unclassified (pre-2012) initiated 13 Sep 2005
In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.

1 jurisdiction

United States — FDA 510(k) Active

510(k)