Cleared Traditional

RISTOCETIN PLATELET AGGREGA-REAGENT TEST

K832929 · Sigma Chemical Co. · Chemistry
Sep 1983
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K832929 is an FDA 510(k) clearance for the RISTOCETIN PLATELET AGGREGA-REAGENT TEST, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983, 36 days after receiving the submission on August 24, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K832929 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1983
Decision Date September 29, 1983
Days to Decision 36 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