BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR— 510(k) K012960
Substantially EquivalentBiogenex Laboratories
FDA 510(k) clearance K012960 for BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR, Substantially Equivalent on 2002-03-08. Applicant: Biogenex Laboratories. Device class: 2.
Clearance details
- Applicant
- Biogenex Laboratories
- Product code
- Code MXZ
- 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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- K171753 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
- K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link) +1 more
More clearances from Biogenex Laboratories
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