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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 -3597
Applicant Contact KAFADER II
Correspondent
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109 -3597
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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