Clearance Summary
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 received FDA 510(k) clearance under submission number K022538, sponsored by Diagnostic Chemicals, Ltd. (Usa). The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-08-23.
- Submission: K022538
- Applicant / Sponsor: Diagnostic Chemicals, Ltd. (Usa)
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1645
- Decision date: 2002-08-23
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.