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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K090939
Device Name ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact MICHELLE L NEFF
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact MICHELLE L NEFF
Regulation Number862.3200
Classification Product Code
DKB  
Subsequent Product Code
DIF  
Date Received04/03/2009
Decision Date 06/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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