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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, Lidocaine
510(k) Number K973102
Device Name LIDOCAINE EIA ASSAY
Applicant
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Correspondent Contact YUH-GENG TSAY
Regulation Number862.3555
Classification Product Code
KLR  
Date Received08/19/1997
Decision Date 09/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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