Cleared Traditional

PLATELET AGGREGATION REAGENT

K850592 · Chrono-Log Corp. · Hematology
May 1985
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K850592 is an FDA 510(k) clearance for the PLATELET AGGREGATION REAGENT, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on May 13, 1985, 87 days after receiving the submission on February 15, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K850592 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1985
Decision Date May 13, 1985
Days to Decision 87 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