Clearance Summary
ARMTROL AND FERMTROL received FDA 510(k) clearance under submission number K780802, sponsored by Biotron , Ltd.. 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 1978-06-13.
- Submission: K780802
- Applicant / Sponsor: Biotron , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1978-06-13
Classification & Regulation
This clearance is catalogued under FDA product code JJW and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.