Clearance Summary
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 received FDA 510(k) clearance under submission number K002174, sponsored by Casco-Nerl Diagnostics Corporation (Maine). 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 2000-08-22.
- Submission: K002174
- Applicant / Sponsor: Casco-Nerl Diagnostics Corporation (Maine)
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2000-08-22
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.