Clearance Summary
ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER received FDA 510(k) clearance under submission number K942753, sponsored by Researched, Novel Medical Devices (Rn/Md). The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1994-11-02.
- Submission: K942753
- Applicant / Sponsor: Researched, Novel Medical Devices (Rn/Md)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1994-11-02
Classification & Regulation
This clearance is catalogued under FDA product code EYZ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.