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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K782100
Device Name HYCEL COUNTER 333
Applicant
Hycel, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hycel, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.5200
Classification Product Code
GKL  
Date Received12/18/1978
Decision Date 01/03/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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