510(k) K031715
K031715 is an FDA 510(k) premarket notification submitted by Applied Imaging Corp. for the device "ARIOL HER-2/NEU IHC". The FDA issued a decision of Substantially Equivalent on January 8, 2004. The device falls under product code NOT (Microscope, Automated, Image Analysis, Operator Intervention), a Class II device regulated under 21 CFR 864.1860. Applied Imaging Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2004
- Date Received
- June 2, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microscope, Automated, Image Analysis, Operator Intervention
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.