Clearance Summary
CHEM-ASSAY STANDARD-CONTROLS received FDA 510(k) clearance under submission number K802962, sponsored by National Bio-Technical Laboratories. 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 1980-12-22.
- Submission: K802962
- Applicant / Sponsor: National Bio-Technical Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1980-12-22
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.