Clearance Summary
ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. received FDA 510(k) clearance under submission number K761236, sponsored by Behring Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1976-12-30.
- Submission: K761236
- Applicant / Sponsor: Behring Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4540
- Decision date: 1976-12-30
Classification & Regulation
This clearance is catalogued under FDA product code JZW and 21 CFR 866.4540, within the Immunology review panel as a Class I device.