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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, Phenobarbital
510(k) Number K872397
Device Name COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
Applicant
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109
Applicant Contact KAFADER II
Correspondent
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109
Correspondent Contact KAFADER II
Regulation Number862.3660
Classification Product Code
LGQ  
Date Received06/22/1987
Decision Date 07/21/1987
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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