Cleared Traditional

AGGRO/LINK CONTROL SOFTWARE

K932566 · Chrono-Log Corp. · Hematology
Nov 1993
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K932566 is an FDA 510(k) clearance for the AGGRO/LINK CONTROL SOFTWARE, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on November 2, 1993, 159 days after receiving the submission on May 27, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K932566 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1993
Decision Date November 02, 1993
Days to Decision 159 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