510(k) K033380
K033380 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "BAYER SPECIAL CHEMISTRY CALIBRATORS". The FDA issued a decision of Substantially Equivalent on December 16, 2003. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2003
- Date Received
- October 22, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type