Clearance Summary
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE received FDA 510(k) clearance under submission number K011052, sponsored by Ostex Intl., 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 2001-07-30.
- Submission: K011052
- Applicant / Sponsor: Ostex Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1400
- Decision date: 2001-07-30
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.