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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 K042407
Device Name EMIT CAFFEINE ASSAY
Applicant
Dade Behring, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714
Applicant Contact YUK-TING LEWIS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714
Correspondent Contact YUK-TING LEWIS
Regulation Number862.3880
Classification Product Code
KLS  
Date Received09/03/2004
Decision Date 10/28/2004
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
Predetermined Change
Control Plan Authorized		 No
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