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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, Carbamazepine
510(k) Number K942687
Device Name IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00
Applicant
Instrumentation Laboratory CO
101 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact WALLIS W CADY
Correspondent
Instrumentation Laboratory CO
101 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact WALLIS W CADY
Regulation Number862.3645
Classification Product Code
KLT  
Subsequent Product Code
DLJ  
Date Received06/07/1994
Decision Date 01/25/1995
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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