Clearance Summary
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE received FDA 510(k) clearance under submission number K112430, sponsored by Abbott Pont of Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-12-20.
- Submission: K112430
- Applicant / Sponsor: Abbott Pont of Care, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1450
- Decision date: 2011-12-20
Classification & Regulation
This clearance is catalogued under FDA product code KHP and 21 CFR 862.1450, within the Clinical Chemistry review panel as a Class I device.