510(k) K022668
K022668 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD". The FDA issued a decision of Substantially Equivalent on October 15, 2002. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2002
- Date Received
- August 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type