Clearance Summary
PANTRAK E.K. received FDA 510(k) clearance under submission number K810669, sponsored by Calbiochem-Behring Corp.. 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 1981-03-31.
- Submission: K810669
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 1981-03-31
Classification & Regulation
This clearance is catalogued under FDA product code CIW and 21 CFR 862.1070, within the Clinical Chemistry review panel as a Class II device.