Clearance Summary
SASI-DC1TS received FDA 510(k) clearance under submission number K970580, sponsored by Substance Abuse Specialties, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1997-04-17.
- Submission: K970580
- Applicant / Sponsor: Substance Abuse Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3250
- Decision date: 1997-04-17
Classification & Regulation
This clearance is catalogued under FDA product code KDW and 21 CFR 864.3250, within the Pathology review panel as a Class I device.