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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, Phenobarbital
510(k) Number K860365
Device Name PHENOBARBITAL TEST SYSTEM
Applicant
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received02/03/1986
Decision Date 03/17/1986
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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