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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 K852568
Device Name MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact JAN BAKER
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact JAN BAKER
Regulation Number864.2220
Classification Product Code
KIT  
Date Received06/18/1985
Decision Date 07/12/1985
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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