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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K862587
Device Name CHEMTROL(TM)
Applicant
G.B.F. INDUSTRIES, INC.
119 WEST 57TH ST.
NEW YORK,  NY  10019
Applicant Contact DONALD J NEDBALSKY
Correspondent
G.B.F. INDUSTRIES, INC.
119 WEST 57TH ST.
NEW YORK,  NY  10019
Correspondent Contact DONALD J NEDBALSKY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/07/1986
Decision Date 08/04/1986
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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