Clearance Summary
TOX PERFECT B TUBES AND REAGENTS received FDA 510(k) clearance under submission number K952501, 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 1995-08-24.
- Submission: K952501
- Applicant / Sponsor: Chimera Research & Chemical, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1995-08-24
Classification & Regulation
This clearance is catalogued under FDA product code DPM and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.