Cleared Traditional

COULTER GEN-S SYSTEM

K962988 · Coulter Corp. · Hematology
Oct 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K962988 is an FDA 510(k) clearance for the COULTER GEN-S SYSTEM, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on October 30, 1996, 90 days after receiving the submission on August 1, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K962988 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1996
Decision Date October 30, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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