Clearance Summary
TYROSINE 50-HOUR REAGENT KIT received FDA 510(k) clearance under submission number K970093, sponsored by Astoria-Pacific, 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 1998-03-19.
- Submission: K970093
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1730
- Decision date: 1998-03-19
Classification & Regulation
This clearance is catalogued under FDA product code CDR and 21 CFR 862.1730, within the Clinical Chemistry review panel as a Class I device.