510(k) K926066
K926066 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION MUMPS-G ANTIBODY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 15, 1993. The device falls under product code CAR (Monitor, Spinal-Fluid Pressure, Electrically Powered), a Class II device regulated under 21 CFR 880.2460. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1993
- Date Received
- December 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Spinal-Fluid Pressure, Electrically Powered
- Device Class
- Class II
- Regulation Number
- 880.2460
- Review Panel
- HO
- Submission Type