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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 K993031
Device Name ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
Applicant
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number862.3660
Classification Product Code
DLZ  
Subsequent Product Code
DLJ  
Date Received09/09/1999
Decision Date 01/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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