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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Cell Counter, Normal And Abnormal
510(k) Number K942209
Device Name LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
Applicant
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Applicant Contact DONNA CHAPMAN
Correspondent
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Correspondent Contact DONNA CHAPMAN
Regulation Number864.8625
Classification Product Code
JCN  
Date Received05/05/1994
Decision Date 06/16/1994
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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