510(k) K160922
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) by
Dako North America, Inc.
— Product Code MXZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2016
- Date Received
- April 4, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunohistochemistry Assay, Antibody, Progesterone Receptor
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type