Clearance Summary
RAPID ACID FAST STAIN received FDA 510(k) clearance under submission number K864033, sponsored by Sigma Diagnostics, 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 1986-11-13.
- Submission: K864033
- Applicant / Sponsor: Sigma Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1986-11-13
Classification & Regulation
This clearance is catalogued under FDA product code KJY and 21 CFR 864.1850, within the Hematology review panel as a Class I device.