Clearance Summary
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS received FDA 510(k) clearance under submission number K905829, sponsored by Kamiya Biomedical Co.. 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 1991-01-30.
- Submission: K905829
- Applicant / Sponsor: Kamiya Biomedical Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1575
- Decision date: 1991-01-30
Classification & Regulation
This clearance is catalogued under FDA product code CEL and 21 CFR 862.1575, within the Clinical Chemistry review panel as a Class I device.