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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media and components, synthetic cell and tissue culture
510(k) Number K871191
Device Name (DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE
Applicant
SIGMA CHEMICAL CO.
P.O. BOX 14508
ST. LOUIS,  MO  63178
Applicant Contact DAVID BAGLEY
Correspondent
SIGMA CHEMICAL CO.
P.O. BOX 14508
ST. LOUIS,  MO  63178
Correspondent Contact DAVID BAGLEY
Regulation Number864.2220
Classification Product Code
KIT  
Date Received03/24/1987
Decision Date 04/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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