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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 K875182
Device Name MODIFIED LABELING FOR TOXI-LAB THC SCREEN
Applicant
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Applicant Contact GUINTY, JR
Correspondent
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Correspondent Contact GUINTY, JR
Regulation Number862.3870
Classification Product Code
DKE  
Date Received12/17/1987
Decision Date 07/05/1988
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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