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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Enterobacteriaceae
510(k) Number K853009
Device Name COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
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 Number866.2660
Classification Product Code
JSS  
Date Received07/16/1985
Decision Date 03/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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