Clearance Summary
SACCOMANNO SPECIMAN SOLUTION received FDA 510(k) clearance under submission number K862725, sponsored by Mill-Rose Laboratory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1986-08-01.
- Submission: K862725
- Applicant / Sponsor: Mill-Rose Laboratory
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1986-08-01
Classification & Regulation
This clearance is catalogued under FDA product code LDZ and 21 CFR 864.4010, within the Pathology review panel as a Class I device.