Cleared Traditional

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA

K061991 · Helena Laboratories · Hematology
Feb 2007
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K061991 is an FDA 510(k) clearance for the PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA, a Reagent, Platelet Aggregation (Class II — Special Controls, product code GHR), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on February 23, 2007, 225 days after receiving the submission on July 13, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K061991 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2006
Decision Date February 23, 2007
Days to Decision 225 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GHR — Reagent, Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700