Clearance Summary
FORMALIN SOLUTION 10% NEUTRAL BUFFER received FDA 510(k) clearance under submission number K840926, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1984-03-12.
- Submission: K840926
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1984-03-12
Classification & Regulation
This clearance is catalogued under FDA product code IFP and 21 CFR 864.4010, within the Pathology review panel as a Class I device.