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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 K011528
Device Name EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
Applicant
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95135 -1500
Applicant Contact SUSAN COLLINS
Correspondent
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95135 -1500
Correspondent Contact SUSAN COLLINS
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received05/17/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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