510(k) K170028
K170028 is an FDA 510(k) premarket notification submitted by Dako Denmark A/S for the device "FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)". The FDA issued a decision of Substantially Equivalent on December 21, 2017. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Dako Denmark A/S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2017
- Date Received
- January 3, 2017
- 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