Cleared Traditional

K012701 - ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
(FDA 510(k) Clearance)

K012701 · Accumetrics, Inc. · Hematology

Jun 2002

Decision

302d

Days

Class 2

Risk

K012701 is an FDA 510(k) clearance for the ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA), a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Accumetrics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 12, 2002, 302 days after receiving the submission on August 14, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number	K012701 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2001
Decision Date	June 12, 2002
Days to Decision	302 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF