Clearance Summary
USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 received FDA 510(k) clearance under submission number K931227, sponsored by U.S. Drug Testing, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1993-05-06.
- Submission: K931227
- Applicant / Sponsor: U.S. Drug Testing, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1993-05-06
Classification & Regulation
This clearance is catalogued under FDA product code KZR and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.