510(k) K023584
K023584 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "ASCENSIA DEX 2 DIABETES CARE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 20, 2002. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2002
- Date Received
- October 25, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type