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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 K843826
Device Name COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
Applicant
Roche Diagnostic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Roche Diagnostic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3880
Classification Product Code
LGS  
Date Received09/28/1984
Decision Date 02/01/1985
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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