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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K850160
Device Name FISHER DIAGNOSTICS LATEST-CRP TEST KIT
Applicant
FISHER DIAGNOSTICS
526 ROUTE 303
ORANGEBURG,  NY  10962
Applicant Contact CHARLES B BREUER
Correspondent
FISHER DIAGNOSTICS
526 ROUTE 303
ORANGEBURG,  NY  10962
Correspondent Contact CHARLES B BREUER
Regulation Number866.5270
Classification Product Code
DCK  
Date Received01/15/1985
Decision Date 04/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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