510(k) K042015
K042015 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, Diagnostics Division for the device "ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE". The FDA issued a decision of Substantially Equivalent on Sep 29, 2004. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Bayer Healthcare, Diagnostics Division has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2004
- Date Received
- Jul 27, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)