Clearance Summary
HLA CONTROL SERA received FDA 510(k) clearance under submission number K791118, sponsored by Calbiochem-Behring Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-08-03.
- Submission: K791118
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 1979-08-03
Classification & Regulation
This clearance is catalogued under FDA product code LGO and 21 CFR 864.7675, within the Hematology review panel as a Class I device.