CO2 CALIBRATOR/DILUENT
FDA 510(k) clearance K033643 · decided 2004-01-08
Clearance details
- K-number
- K033643
- Device name
- CO2 CALIBRATOR/DILUENT
- Applicant
- Bayer Healthcare, Diagnostics Division
- Decision
- Substantially Equivalent
- Date received
- 2003-11-20
- Decision date
- 2004-01-08
- Days to decision
- 49 days
- Clearance type
- Abbreviated
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- 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 |