Clearance Summary
HELENA FETAL-TEK 200 METHOD received FDA 510(k) clearance under submission number K811588, sponsored by Helena Laboratories. 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 1981-06-25.
- Submission: K811588
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1455
- Decision date: 1981-06-25
Classification & Regulation
This clearance is catalogued under FDA product code JHG and 21 CFR 862.1455, within the Clinical Chemistry review panel as a Class II device.