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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K864993
Device Name QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
Applicant
General Diagnostics
160 Community Dr.
Great Neck,  NY  11021
Applicant Contact SUSAN M DURHAM
Correspondent
General Diagnostics
160 Community Dr.
Great Neck,  NY  11021
Correspondent Contact SUSAN M DURHAM
Regulation Number862.3150
Classification Product Code
DIS  
Date Received12/22/1986
Decision Date 03/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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