Clearance Summary
FETAL HEMOGLOBIN received FDA 510(k) clearance under submission number K892241, sponsored by Sure-Tech Diagnostic Associates, 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 1989-05-17.
- Submission: K892241
- Applicant / Sponsor: Sure-Tech Diagnostic Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7455
- Decision date: 1989-05-17
Classification & Regulation
This clearance is catalogued under FDA product code GHQ and 21 CFR 864.7455, within the Hematology review panel as a Class II device.