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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, Benzodiazepine
510(k) Number K926067
Device Name EMIT(R) II BENZODIAZEPINE ASSAY
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135 -1500
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135 -1500
Correspondent Contact PAUL L ROGERS
Regulation Number862.3170
Classification Product Code
JXM  
Date Received12/01/1992
Decision Date 01/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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