Clearance Summary
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) received FDA 510(k) clearance under submission number K991362, sponsored by Morax. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1999-06-21.
- Submission: K991362
- Applicant / Sponsor: Morax
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7440
- Decision date: 1999-06-21
Classification & Regulation
This clearance is catalogued under FDA product code JBD and 21 CFR 864.7440, within the Hematology review panel as a Class II device.