Clearance Summary
REP 3 FLUR SPE-60 KIT received FDA 510(k) clearance under submission number K964453, 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 1996-12-23.
- Submission: K964453
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1630
- Decision date: 1996-12-23
Classification & Regulation
This clearance is catalogued under FDA product code CEF and 21 CFR 862.1630, within the Clinical Chemistry review panel as a Class I device.