Cleared Traditional

AGGRO/LINK VW COFACTOR SOFTWARE

K940792 · Chrono-Log Corp. · Hematology
Oct 1994
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K940792 is an FDA 510(k) clearance for the AGGRO/LINK VW COFACTOR SOFTWARE, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on October 13, 1994, 233 days after receiving the submission on February 22, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K940792 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1994
Decision Date October 13, 1994
Days to Decision 233 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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