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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K852372
Device Name CELL-DYN BRAND HEMATOLOGY REAGENTS
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Applicant Contact RUTH M BECKER
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent Contact RUTH M BECKER
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/04/1985
Decision Date 09/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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