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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 K851737
Device Name MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &
Applicant
Sigma
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact JAN BAKER
Correspondent
Sigma
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact JAN BAKER
Regulation Number864.2220
Classification Product Code
KIT  
Date Received04/25/1985
Decision Date 05/15/1985
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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