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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Her-2/Neu, Monitoring
510(k) Number K994112
Device Name MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
Applicant
Oncogene Science, Inc.
80 Rogers St.
Cambridge,  MA  02142
Applicant Contact WALTER P CARNEY
Correspondent
Oncogene Science, Inc.
80 Rogers St.
Cambridge,  MA  02142
Correspondent Contact WALTER P CARNEY
Regulation Number866.6010
Classification Product Code
NCW  
Date Received12/06/1999
Decision Date 09/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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