ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
FDA 510(k) clearance K042015 · decided 2004-09-29
Clearance details
- K-number
- K042015
- Device name
- ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
- Applicant
- Bayer Healthcare, Diagnostics Division
- Decision
- Substantially Equivalent
- Date received
- 2004-07-27
- Decision date
- 2004-09-29
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS (P040017) | Bayer Healthcare, Diagnostics Division | 2005-03-07 |