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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 K881116
Device Name EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
Applicant
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.3555
Classification Product Code
KLR  
Date Received03/15/1988
Decision Date 06/20/1988
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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