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510(k) K013148

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) by Biogenex Laboratories — Product Code MYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2002
Date Received
September 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

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  • K820724 — FLUOROGEN PAP FIA (April 14, 1982)

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