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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K851151
Device Name FISHER DIAGNOSTICS KDA CALIBRATOR II
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 Number862.1150
Classification Product Code
JIX  
Date Received03/21/1985
Decision Date 05/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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