Clearance Summary
REAGENTS received FDA 510(k) clearance under submission number K761086, sponsored by Simmler & Son, 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 1977-01-12.
- Submission: K761086
- Applicant / Sponsor: Simmler & Son, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2150
- Decision date: 1977-01-12
Classification & Regulation
This clearance is catalogued under FDA product code JJC and 21 CFR 862.2150, within the Clinical Chemistry review panel as a Class I device.