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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyanomethemoglobin Reagent And Standard Solution
510(k) Number K881242
Device Name CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
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 Number864.7500
Classification Product Code
GJZ  
Date Received03/16/1988
Decision Date 04/21/1988
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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