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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, Tobramycin
510(k) Number K964670
Device Name ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Applicant Contact RITA SMITH
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Correspondent Contact RITA SMITH
Regulation Number862.3900
Classification Product Code
LFW  
Date Received11/21/1996
Decision Date 02/04/1997
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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