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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 K881000
Device Name KERATINOCYTE GROWTH MEDIUM (KGM)
Applicant
Clonetics Corp.
9620 Chesapeake Dr.
Suite 206
San Diego,  CA  92123
Applicant Contact MICHAEL C LUECKE
Correspondent
Clonetics Corp.
9620 Chesapeake Dr.
Suite 206
San Diego,  CA  92123
Correspondent Contact MICHAEL C LUECKE
Regulation Number864.2220
Classification Product Code
KIT  
Date Received03/08/1988
Decision Date 03/21/1988
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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