BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)— 510(k) K013148

Substantially Equivalent

Biogenex Laboratories

FDA 510(k) clearance K013148 for BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88), Substantially Equivalent on 2002-02-28. Applicant: Biogenex Laboratories.

Clearance details

Applicant: Biogenex Laboratories
Product code: Code MYA
Advisory panel: Hematology
Date received: 2001-09-20
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

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