Clearance Summary
NUCLEAR ENTERPRISES 1612 MULTI-WELL received FDA 510(k) clearance under submission number K801263, sponsored by Nuclear Ent. , 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 1980-06-20.
- Submission: K801263
- Applicant / Sponsor: Nuclear Ent. , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1980-06-20
Classification & Regulation
This clearance is catalogued under FDA product code JJJ and 21 CFR 862.2320, within the Clinical Chemistry review panel as a Class I device.