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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 K873092
Device Name RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU.
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact DAVID K BAGLEY
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact DAVID K BAGLEY
Regulation Number864.2220
Classification Product Code
KIT  
Date Received08/06/1987
Decision Date 08/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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