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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drug specific control materials
510(k) Number K780142
Device Name ANTICONVULSANT CONTROL SERUM
Applicant
MCDONNELL DOUGLAS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MCDONNELL DOUGLAS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.3280
Classification Product Code
LAS  
Date Received01/26/1978
Decision Date 02/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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