Clearance Summary
LYNX EL MICROSCOPY TISSUE PROCESSOR received FDA 510(k) clearance under submission number K862457, sponsored by Australian Biomedical Corporation , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1986-07-16.
- Submission: K862457
- Applicant / Sponsor: Australian Biomedical Corporation , Ltd.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1986-07-16
Classification & Regulation
This clearance is catalogued under FDA product code IDZ and 21 CFR 864.3010, within the Pathology review panel as a Class I device.