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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 K833393
Device Name ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM
Applicant
Sigma Chemical Co.
1831 Olive St. St. Louis,  MO 
Correspondent
Sigma Chemical Co.
1831 Olive St. St. Louis,  MO 
Regulation Number864.2220
Classification Product Code
KIT  
Date Received09/28/1983
Decision Date 11/03/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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