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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, Cocaine
510(k) Number K923314
Device Name AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
Applicant
Serex, Inc.
230 W. Passaic St.
Maywood,  NJ  07607
Applicant Contact VICTOR LEE-OWN
Correspondent
Serex, Inc.
230 W. Passaic St.
Maywood,  NJ  07607
Correspondent Contact VICTOR LEE-OWN
Regulation Number862.3250
Classification Product Code
JXO  
Date Received07/07/1992
Decision Date 08/24/1992
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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