510(k) K033643
K033643 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, Diagnostics Division for the device "CO2 CALIBRATOR/DILUENT". The FDA issued a decision of Substantially Equivalent on Jan 8, 2004. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Bayer Healthcare, Diagnostics Division has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 2004
- Date Received
- Nov 20, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Calibrator, Secondary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type
- 510(k) Exempt