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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lymphocyte Separation Medium
510(k) Number K842146
Device Name HISTOPAQUE-1077
Applicant
SIGMA CHEMICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SIGMA CHEMICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.8500
Classification Product Code
JCF  
Date Received05/30/1984
Decision Date 07/27/1984
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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