COUNTER 700 & HC-700 HEMO 0 REF.

Counter, Cell, Automated (particle Counter)

HYCEL, INC.

The following data is part of a premarket notification filed by Hycel, Inc. with the FDA for Counter 700 & Hc-700 Hemo 0 Ref..

Pre-market Notification Details

Device IDK771107
510k NumberK771107
Device Name:COUNTER 700 & HC-700 HEMO 0 REF.
ClassificationCounter, Cell, Automated (particle Counter)
Applicant HYCEL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-06-20
Decision Date1977-07-11

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