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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 K820323
Device Name EMIT AND NETILMICIN CONTROL
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 Number862.3280
Classification Product Code
LAS  
Date Received02/05/1982
Decision Date 02/23/1982
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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