Cleared Traditional

HYCEL COUNTER 211

K782102 · Hycel, Inc. · Hematology
Jan 1979
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K782102 is an FDA 510(k) clearance for the HYCEL COUNTER 211, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Hycel, Inc. (Walker, US). The FDA issued a Cleared decision on January 3, 1979, 16 days after receiving the submission on December 18, 1978. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K782102 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1978
Decision Date January 03, 1979
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

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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