510(k) K141374
K141374 is an FDA 510(k) premarket notification submitted by Beckman Coulter Ireland, Inc. for the device "BICARBONATE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on June 30, 2014. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Beckman Coulter Ireland, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2014
- Date Received
- May 27, 2014
- 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