Clearance Summary
HICHEM ISE STANDARDS KIT 70011 received FDA 510(k) clearance under submission number K953863, sponsored by Hichem Diagnostics. 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 1995-09-06.
- Submission: K953863
- Applicant / Sponsor: Hichem Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 1995-09-06
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.