Clearance Summary
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 received FDA 510(k) clearance under submission number K003609, sponsored by Osteometer Biotech A/S. 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 2001-05-16.
- Submission: K003609
- Applicant / Sponsor: Osteometer Biotech A/S
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 2001-05-16
Classification & Regulation
This clearance is catalogued under FDA product code NEO and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.