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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemistry Antibody Assay, Estrogen Receptor
510(k) Number K013148
Device Name BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
Applicant
Biogenex Laboratories
4600 Norris Canyon Rd.
San Ramon,  CA  94583
Applicant Contact GURVINDER S NANDA
Correspondent
Biogenex Laboratories
4600 Norris Canyon Rd.
San Ramon,  CA  94583
Correspondent Contact GURVINDER S NANDA
Regulation Number864.1860
Classification Product Code
MYA  
Date Received09/20/2001
Decision Date 02/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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