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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 K862318
Device Name FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
Applicant
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Applicant Contact CHARLES B BREUER
Correspondent
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Correspondent Contact CHARLES B BREUER
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/18/1986
Decision Date 07/10/1986
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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