Cleared Traditional

AGGRO/LINK COMPUTER INTERFACE

K851025 · Chrono-Log Corp. · Hematology
Jun 1985
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K851025 is an FDA 510(k) clearance for the AGGRO/LINK COMPUTER INTERFACE, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on June 12, 1985, 93 days after receiving the submission on March 11, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K851025 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1985
Decision Date June 12, 1985
Days to Decision 93 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