BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)— 510(k) K013148
Substantially EquivalentBiogenex Laboratories
FDA 510(k) clearance K013148 for BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88), Substantially Equivalent on 2002-02-28. Applicant: Biogenex Laboratories. Device class: 2.
Clearance details
- Applicant
- Biogenex Laboratories
- Product code
- Code MYA
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Ramon, CA, US
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More clearances from Biogenex Laboratories
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