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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 K945207
Device Name MECTEST
Applicant
Meco Industries
P.O. Box 1070
Walnut,  CA  91788
Applicant Contact EUGENE A ESGUERRA
Correspondent
Meco Industries
P.O. Box 1070
Walnut,  CA  91788
Correspondent Contact EUGENE A ESGUERRA
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   LAT  
Date Received10/25/1994
Decision Date 09/25/1995
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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