Clearance Summary
SERUM CROSSLAPS ONE STEP ELISA received FDA 510(k) clearance under submission number K990843, 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 1999-07-09.
- Submission: K990843
- Applicant / Sponsor: Osteometer Biotech A/S
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1400
- Decision date: 1999-07-09
Classification & Regulation
This clearance is catalogued under FDA product code JMM and 21 CFR 862.1400, within the Clinical Chemistry review panel as a Class I device.