HYCEL COUNTER 333

Counter, Cell, Automated (particle Counter)

HYCEL, INC.

The following data is part of a premarket notification filed by Hycel, Inc. with the FDA for Hycel Counter 333.

Pre-market Notification Details

Device IDK782100
510k NumberK782100
Device Name:HYCEL COUNTER 333
ClassificationCounter, Cell, Automated (particle Counter)
Applicant HYCEL, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-18
Decision Date1979-01-03

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