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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Theophylline
510(k) Number K951169
Device Name CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
Applicant
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact STEVEN R RAKITIN
Correspondent
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact STEVEN R RAKITIN
Regulation Number862.3880
Classification Product Code
LGS  
Date Received03/15/1995
Decision Date 06/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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