Clearance Summary
CR PERFECT received FDA 510(k) clearance under submission number K970087, sponsored by Chimera Research & Chemical, 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 1997-03-06.
- Submission: K970087
- Applicant / Sponsor: Chimera Research & Chemical, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 1997-03-06
Classification & Regulation
This clearance is catalogued under FDA product code CGX and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.