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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, theophylline
510(k) Number K042520
Device Name VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact CAREY A MAYO
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact CAREY A MAYO
Regulation Number862.3880
Classification Product Code
KLS  
Subsequent Product Code
DIF  
Date Received09/16/2004
Decision Date 11/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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