Cleared Traditional

ARACHIDONIC ACID

K811290 · Bio/Data Corp. · Chemistry
Jul 1981
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K811290 is an FDA 510(k) clearance for the ARACHIDONIC ACID, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981, 77 days after receiving the submission on May 11, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K811290 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1981
Decision Date July 27, 1981
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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