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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Morphine
510(k) Number K990409
Device Name ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
Applicant
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Applicant Contact JENNIFER L TRIBBETT
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Correspondent Contact JENNIFER L TRIBBETT
Regulation Number862.3640
Classification Product Code
DMY  
Date Received02/09/1999
Decision Date 04/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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