Clearance Summary
ATS TB RAPID STAIN SET PRODUCT #034-45 received FDA 510(k) clearance under submission number K890148, sponsored by Alpha-Tec Systems, 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 1989-01-24.
- Submission: K890148
- Applicant / Sponsor: Alpha-Tec Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1989-01-24
Classification & Regulation
This clearance is catalogued under FDA product code ICL and 21 CFR 864.1850, within the Hematology review panel as a Class I device.