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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Opiates
510(k) Number K932209
Device Name TOXI*LAB LTD OPIATE SYSTEM
Applicant
Toxi-Lab, Inc.
2 Goodyear
Irvine,  CA  92718
Applicant Contact LORNA GAMBOA
Correspondent
Toxi-Lab, Inc.
2 Goodyear
Irvine,  CA  92718
Correspondent Contact LORNA GAMBOA
Regulation Number862.3650
Classification Product Code
LAI  
Date Received05/06/1993
Decision Date 09/24/1993
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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