Cleared Traditional

ARACHIDONIC ACID

K912774 · Helena Laboratories · Hematology
Aug 1991
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K912774 is an FDA 510(k) clearance for the ARACHIDONIC ACID, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 22, 1991, 59 days after receiving the submission on June 24, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K912774 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1991
Decision Date August 22, 1991
Days to Decision 59 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JBX — Aggregrometer, Platelet
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6675