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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, Morphine
510(k) Number K853140
Device Name MDI QUIK TEST NARCOTICS DRUG SCREEN
Applicant
Medical Diagnostics, Ca.
9062 Rte. 108
Columbia,  MD  21045
Applicant Contact FRANK 0 HOLCOMBE
Correspondent
Medical Diagnostics, Ca.
9062 Rte. 108
Columbia,  MD  21045
Correspondent Contact FRANK 0 HOLCOMBE
Regulation Number862.3640
Classification Product Code
DNK  
Date Received07/29/1985
Decision Date 03/03/1986
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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