Cleared Traditional

ASSERACHROM B-TG KIT

K862775 · American Bioproducts Co. · Hematology
Oct 1986
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K862775 is an FDA 510(k) clearance for the ASSERACHROM B-TG KIT, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on October 22, 1986, 92 days after receiving the submission on July 22, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K862775 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1986
Decision Date October 22, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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