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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 K961462
Device Name CEDIA THEOPHYLLINE ASSAY
Applicant
Boehringer Mannheim Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact BETSY SOARES-MADDOX
Correspondent
Boehringer Mannheim Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact BETSY SOARES-MADDOX
Regulation Number862.3880
Classification Product Code
KLS  
Date Received04/17/1996
Decision Date 06/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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