Clearance Summary
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 received FDA 510(k) clearance under submission number K994035, sponsored by Diagnostic Chemicals , Ltd.. 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 2000-02-01.
- Submission: K994035
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1645
- Decision date: 2000-02-01
Classification & Regulation
This clearance is catalogued under FDA product code JIR and 21 CFR 862.1645, within the Clinical Chemistry review panel as a Class I device.