510(k) K032113
K032113 is an FDA 510(k) premarket notification submitted by Chroma Vision Medical Systems, Inc. for the device "ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)". The FDA issued a decision of Substantially Equivalent on December 23, 2003. The device falls under product code NOT (Microscope, Automated, Image Analysis, Operator Intervention), a Class II device regulated under 21 CFR 864.1860. Chroma Vision Medical Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2003
- Date Received
- July 9, 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.