Clearance Summary
CARA-STAIN MODEL 3000 received FDA 510(k) clearance under submission number K771699, sponsored by American Safety Equipment Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1977-09-13.
- Submission: K771699
- Applicant / Sponsor: American Safety Equipment Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3800
- Decision date: 1977-09-13
Classification & Regulation
This clearance is catalogued under FDA product code KPA and 21 CFR 864.3800, within the Pathology review panel as a Class I device.