510(k) K992228
K992228 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "BAYER IMMUNO 1 HER-2/NEU ASSAY". The FDA issued a decision of Substantially Equivalent on September 29, 2000. The device falls under product code NCW (System, Test, Her-2/Neu, Monitoring), a Class II device regulated under 21 CFR 866.6010. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2000
- Date Received
- July 2, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Her-2/Neu, Monitoring
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type