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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name immunohistochemistry assay, antibody, progesterone receptor
510(k) Number K012960
Device Name BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
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
MXZ  
Date Received09/04/2001
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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