510(k) K122556
K122556 is an FDA 510(k) premarket notification submitted by Leica Biosystems Newcastle, Ltd. for the device "VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)". The FDA issued a decision of Substantially Equivalent on May 19, 2014. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Leica Biosystems Newcastle, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2014
- Date Received
- August 22, 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