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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, Diphenylhydantoin
510(k) Number K011347
Device Name EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
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 Number862.3350
Classification Product Code
DIP  
Date Received05/02/2001
Decision Date 05/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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