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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 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
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
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