Clearance Summary
PCTE MICROPOROUS MEMBRANE FILTER received FDA 510(k) clearance under submission number K870196, sponsored by Poretics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1987-05-12.
- Submission: K870196
- Applicant / Sponsor: Poretics Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1987-05-12
Classification & Regulation
This clearance is catalogued under FDA product code KET and 21 CFR 864.3010, within the Pathology review panel as a Class I device.