BAYER SPECIAL CHEMISTRY CALIBRATORS
FDA 510(k) clearance K033380 · decided 2003-12-16
Clearance details
- K-number
- K033380
- Device name
- BAYER SPECIAL CHEMISTRY CALIBRATORS
- Applicant
- Bayer Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-22
- Decision date
- 2003-12-16
- Days to decision
- 55 days
- Clearance type
- Abbreviated
- Product code
- JIX
- 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.