Clearance Summary
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET received FDA 510(k) clearance under submission number K853081, sponsored by Advanced Medical Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-08-13.
- Submission: K853081
- Applicant / Sponsor: Advanced Medical Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1985-08-13
Classification & Regulation
This clearance is catalogued under FDA product code KJK and 21 CFR 864.1850, within the Hematology review panel as a Class I device.