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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Vancomycin
510(k) Number K953528
Device Name ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
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 Number862.3950
Classification Product Code
LEH  
Date Received07/27/1995
Decision Date 09/12/1995
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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