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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 And Cocaine Metabolites
510(k) Number K980153
Device Name DRUG CHECK
Applicant
Texas Immunology, Inc.
5400 Spur 248
Tyler,  TX  75707
Applicant Contact CHARLES W GILL
Correspondent
Texas Immunology, Inc.
5400 Spur 248
Tyler,  TX  75707
Correspondent Contact CHARLES W GILL
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DKZ   DPK   LCM   LDJ  
Date Received01/16/1998
Decision Date 03/27/1998
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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