510(k) K120663
K120663 is an FDA 510(k) premarket notification submitted by Dako North America, Inc. for the device "MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI". The FDA issued a decision of Substantially Equivalent on February 12, 2013. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Dako North America, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2013
- Date Received
- March 5, 2012
- 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