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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Theophylline
510(k) Number K905521
Device Name CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
Applicant
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact Patricia M Klimley
Correspondent
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact Patricia M Klimley
Regulation Number862.3880
Classification Product Code
LER  
Date Received12/07/1990
Decision Date 12/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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