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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K080183
Device Name CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
Applicant
Roche Diagnostics Corp.
9115 Hague Rd. Bx 50416
Indianapolis,  IN  46250
Applicant Contact DIMITRIS DEMIRTZOGLOU
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd. Bx 50416
Indianapolis,  IN  46250
Correspondent Contact DIMITRIS DEMIRTZOGLOU
Regulation Number862.3280
Classification Product Code
DIF  
Date Received01/25/2008
Decision Date 03/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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