Clearance Summary
EQUIPMENT/MATERIAL DECONTAMINATING KIT received FDA 510(k) clearance under submission number K911299, sponsored by Rohm and Haas Co.. 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 1991-04-08.
- Submission: K911299
- Applicant / Sponsor: Rohm and Haas Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1991-04-08
Classification & Regulation
This clearance is catalogued under FDA product code KIE and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.