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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
Original Applicant
SIGMA CHEMICAL CO.
p.o. box 14508
st. louis,  MO  63178
Original Contact david bagley
Regulation Number864.2220
Classification Product Code
KIT  
Date Received03/24/1987
Decision Date 04/03/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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