510(k) K984567
K984567 is an FDA 510(k) premarket notification submitted by Ventana, Inc. for the device "VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)". The FDA issued a decision of Substantially Equivalent on August 12, 1999. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1999
- Date Received
- December 23, 1998
- 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