ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE— 510(k) K042015
Substantially EquivalentBayer Healthcare, Diagnostics Division
FDA 510(k) clearance K042015 for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE, Substantially Equivalent on 2004-09-29. Applicant: Bayer Healthcare, Diagnostics Division. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, Diagnostics Division
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code CGA
view allMore clearances from Bayer Healthcare, Diagnostics Division
view allAdverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K042015
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042015.
Data sourced from openFDA. This site is unofficial and independent of the FDA.