Clearance Summary
HEMOGLOBIN received FDA 510(k) clearance under submission number K883683, sponsored by Tech-Co, 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 1988-10-06.
- Submission: K883683
- Applicant / Sponsor: Tech-Co, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7500
- Decision date: 1988-10-06
Classification & Regulation
This clearance is catalogued under FDA product code GJZ and 21 CFR 864.7500, within the Hematology review panel as a Class II device.