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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K843913
Device Name COBAS FP TDM CONTROLS
Applicant
Roche Diagnostic Systems, Inc.
Nutley,  NJ  07110
Applicant Contact GRIFFIN FITZGERAL
Correspondent
Roche Diagnostic Systems, Inc.
Nutley,  NJ  07110
Correspondent Contact GRIFFIN FITZGERAL
Regulation Number862.3280
Classification Product Code
DIF  
Date Received10/04/1984
Decision Date 10/30/1984
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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