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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram Negative Identification Panel
510(k) Number K923313
Device Name ROCHE OXI/FERM II
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Correspondent Contact CAROL L KRIEGER
Regulation Number866.2660
Classification Product Code
LQM  
Date Received07/07/1992
Decision Date 04/05/1993
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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