Clearance Summary
ASTRA received FDA 510(k) clearance under submission number K811381, sponsored by Chem-Elec, 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 1981-08-13.
- Submission: K811381
- Applicant / Sponsor: Chem-Elec, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1160
- Decision date: 1981-08-13
Classification & Regulation
This clearance is catalogued under FDA product code JFL and 21 CFR 862.1160, within the Clinical Chemistry review panel as a Class II device.