Clearance Summary
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY received FDA 510(k) clearance under submission number K001943, sponsored by Sangui Biotech, 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 2000-08-23.
- Submission: K001943
- Applicant / Sponsor: Sangui Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 2000-08-23
Classification & Regulation
This clearance is catalogued under FDA product code NAO and 21 CFR 862.1360, within the Clinical Chemistry review panel as a Class I device.