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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Test, Tetrahydrocannabinol
510(k) Number K901694
Device Name SPEC(TM) EXTRACTION CARTRIDGE
Applicant
Toxi-Lab, Inc.
2 Goodyear
Irvine,  CA  92718
Applicant Contact MICHAEL O'DONNELL
Correspondent
Toxi-Lab, Inc.
2 Goodyear
Irvine,  CA  92718
Correspondent Contact MICHAEL O'DONNELL
Regulation Number862.3870
Classification Product Code
DKE  
Date Received04/10/1990
Decision Date 06/01/1990
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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