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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 K792282
Device Name DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG
Applicant
California Medical Developments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
California Medical Developments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3870
Classification Product Code
DKE  
Date Received11/13/1979
Decision Date 02/29/1980
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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