Clearance Summary
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE received FDA 510(k) clearance under submission number K013938, sponsored by Diametrics Medical, 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 2002-01-28.
- Submission: K013938
- Applicant / Sponsor: Diametrics Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1450
- Decision date: 2002-01-28
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.