Clearance Summary
PERMACLEAR SOLUTION CAT. NO. 4950 received FDA 510(k) clearance under submission number K861490, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1986-05-06.
- Submission: K861490
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1986-05-06
Classification & Regulation
This clearance is catalogued under FDA product code KEM and 21 CFR 864.4010, within the Pathology review panel as a Class I device.