Clearance Summary
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 received FDA 510(k) clearance under submission number K001285, 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 2000-06-02.
- Submission: K001285
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1065
- Decision date: 2000-06-02
Classification & Regulation
This clearance is catalogued under FDA product code JIF and 21 CFR 862.1065, within the Clinical Chemistry review panel as a Class I device.