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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 K890482
Device Name ABC, ABC-1X, ABC(TM)
Applicant
Cell Ent., Inc.
15719 Crabbs Branch Way
Derwood,  MD  20855
Applicant Contact FREDERICK J DARFLER
Correspondent
Cell Ent., Inc.
15719 Crabbs Branch Way
Derwood,  MD  20855
Correspondent Contact FREDERICK J DARFLER
Regulation Number864.2220
Classification Product Code
KIT  
Date Received01/31/1989
Decision Date 02/10/1989
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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