Clearance Summary
ASSAY REAGENTS, LSA 290 received FDA 510(k) clearance under submission number K790588, sponsored by Kallestad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1979-05-15.
- Submission: K790588
- Applicant / Sponsor: Kallestad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6650
- Decision date: 1979-05-15
Classification & Regulation
This clearance is catalogued under FDA product code JEW and 21 CFR 872.6650, within the Dental review panel as a Class I device.