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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 K854607
Device Name ACCULEVEL PHENOBARBITAL TEST
Applicant
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Applicant Contact ELEANOR V CHIU
Correspondent
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Correspondent Contact ELEANOR V CHIU
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received11/18/1985
Decision Date 08/25/1986
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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