Clearance Summary
REAGENT TESTS STRIP COMBINATIONS received FDA 510(k) clearance under submission number K833521, sponsored by Syn-Kit, 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 1984-01-11.
- Submission: K833521
- Applicant / Sponsor: Syn-Kit, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1115
- Decision date: 1984-01-11
Classification & Regulation
This clearance is catalogued under FDA product code JJB and 21 CFR 862.1115, within the Clinical Chemistry review panel as a Class I device.