Cleared Traditional

COUNTER 700 & HC-700 HEMO 0 REF.

K771107 · Hycel, Inc. · Hematology
Jul 1977
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K771107 is an FDA 510(k) clearance for the COUNTER 700 & HC-700 HEMO 0 REF., a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977, 21 days after receiving the submission on June 20, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K771107 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1977
Decision Date July 11, 1977
Days to Decision 21 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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