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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 K852485
Device Name CELLGRO(ISCOVE'S MEDIUM) MODIFICATION
Applicant
Mediatech, Inc.
13884 Park Center Rd.
Herndon,  VA  20171
Applicant Contact ROBERT R TASCHNER
Correspondent
Mediatech, Inc.
13884 Park Center Rd.
Herndon,  VA  20171
Correspondent Contact ROBERT R TASCHNER
Regulation Number864.2220
Classification Product Code
KIT  
Date Received06/11/1985
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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