Cleared Traditional

K013596 - MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
(FDA 510(k) Clearance)

K013596 · Accumetrics, Inc. · Hematology

May 2002

Decision

197d

Days

Class 2

Risk

K013596 is an FDA 510(k) clearance for the MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP). This device is classified as 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 May 16, 2002, 197 days after receiving the submission on October 31, 2001.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number	K013596 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2001
Decision Date	May 16, 2002
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF