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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 K883942
Device Name HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
Applicant
Icl Scientific
11040 Condor Ave.
Fountain Valley,  CA  92708
Applicant Contact RON HOOVER
Correspondent
Icl Scientific
11040 Condor Ave.
Fountain Valley,  CA  92708
Correspondent Contact RON HOOVER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/19/1988
Decision Date 11/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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