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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 K882663
Device Name BARBITURATE ENZYME IMMUNOASSAY KIT
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 Received06/27/1988
Decision Date 09/19/1988
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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