510(k) K141109
K141109 is an FDA 510(k) premarket notification submitted by Leica Biosystems Imaging, Inc. for the device "APERIO EPATHOLOGY EIHC IVD SYSTEM". The FDA issued a decision of Substantially Equivalent on July 29, 2014. The device falls under product code NOT (Microscope, Automated, Image Analysis, Operator Intervention), a Class II device regulated under 21 CFR 864.1860. Leica Biosystems Imaging, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2014
- Date Received
- April 29, 2014
- 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.