Clearance Summary
GLYCOHEMOGLOBIN-SKREEN TEST KIT received FDA 510(k) clearance under submission number K780819, sponsored by Eppendorf-Brinkmann, 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 1978-11-07.
- Submission: K780819
- Applicant / Sponsor: Eppendorf-Brinkmann, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 1978-11-07
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.