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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 K780466
Device Name EMIT CARBAMAZEPINE ASSAY
Applicant
Syva Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Syva Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3645
Classification Product Code
KLT  
Date Received03/22/1978
Decision Date 04/24/1978
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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