510(k) K994356
K994356 is an FDA 510(k) premarket notification submitted by Diagnocure, Inc. for the device "IMMUNOCYT". The FDA issued a decision of Substantially Equivalent on February 23, 2000. The device falls under product code NBK (System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer), a Class II device regulated under 21 CFR 864.1860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2000
- Date Received
- December 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type