Clearance Summary
TRACE REAGENT LINE FOR THE COBAS MIRA received FDA 510(k) clearance under submission number K973869, sponsored by Trace America, 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 1998-01-07.
- Submission: K973869
- Applicant / Sponsor: Trace America, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 1998-01-07
Classification & Regulation
This clearance is catalogued under FDA product code CKA and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.