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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 K910376
Device Name EMIT II BENZODIAZEPINE ASSAY
Applicant
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact ROGERS, JR.
Regulation Number862.3170
Classification Product Code
JXM  
Date Received01/29/1991
Decision Date 02/22/1991
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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