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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 K920417
Device Name IL TEST BARBITURATE, 35289
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GABRIEL J MURACA
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GABRIEL J MURACA
Regulation Number862.3150
Classification Product Code
DIS  
Date Received01/31/1992
Decision Date 04/24/1992
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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