Clearance Summary
GIBCO MYCOTECT 189-5670 received FDA 510(k) clearance under submission number K851275, sponsored by Gibco Laboratories Life Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-06-21.
- Submission: K851275
- Applicant / Sponsor: Gibco Laboratories Life Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2360
- Decision date: 1985-06-21
Classification & Regulation
This clearance is catalogued under FDA product code KIW and 21 CFR 864.2360, within the Hematology review panel as a Class I device.