Clearance Summary
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY received FDA 510(k) clearance under submission number K896522, sponsored by Casco Standards. 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 1990-01-02.
- Submission: K896522
- Applicant / Sponsor: Casco Standards
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1990-01-02
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.