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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K930890
Device Name COBAS(R) CORE IGE TOTAL EIA
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact CAROL L KRIEGER
Regulation Number866.5510
Classification Product Code
DGC  
Date Received02/22/1993
Decision Date 08/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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