Clearance Summary
ATS PARA-SET CARBOL-XYLENE SOLUTION received FDA 510(k) clearance under submission number K883061, sponsored by Alpha-Tech 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 1988-08-17.
- Submission: K883061
- Applicant / Sponsor: Alpha-Tech Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1988-08-17
Classification & Regulation
This clearance is catalogued under FDA product code JTS and 21 CFR 864.1850, within the Hematology review panel as a Class I device.