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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, phenobarbital
510(k) Number K834216
Device Name EMIT QST PHENOBARBITAL ASSAY
Applicant
SYVA CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SYVA CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received12/05/1983
Decision Date 01/24/1984
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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