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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 K872918
Device Name GIT SERUM-FREE MEDIUM FOR CELL CULTURE
Applicant
Wako Chemicals USA, Inc.
12300 Ford Rd.
Suite 130
Dallas,  TX  75234
Applicant Contact TOSHIHIKO ODA
Correspondent
Wako Chemicals USA, Inc.
12300 Ford Rd.
Suite 130
Dallas,  TX  75234
Correspondent Contact TOSHIHIKO ODA
Regulation Number864.2220
Classification Product Code
KIT  
Date Received07/27/1987
Decision Date 08/11/1987
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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