Clearance Summary
HEPA-SHURE -L received FDA 510(k) clearance under submission number K802120, sponsored by Nuclear Medical Laboratories, 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 1980-10-20.
- Submission: K802120
- Applicant / Sponsor: Nuclear Medical Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2720
- Decision date: 1980-10-20
Classification & Regulation
This clearance is catalogued under FDA product code JJK and 21 CFR 862.2720, within the Clinical Chemistry review panel as a Class I device.