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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 K863224
Device Name HEMATALL-C PLUS HEMATOLOGY CONTROLS
Applicant
FISHER SCIENTIFIC CO., LLC.
526 ROUTE 303
ORANGEBURG,  NY  10962
Applicant Contact CHARLES BREUER,PH.D.
Correspondent
FISHER SCIENTIFIC CO., LLC.
526 ROUTE 303
ORANGEBURG,  NY  10962
Correspondent Contact CHARLES BREUER,PH.D.
Regulation Number864.8625
Classification Product Code
JPK  
Date Received08/21/1986
Decision Date 10/29/1986
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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