Clearance Summary
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS received FDA 510(k) clearance under submission number K854236, sponsored by Nms Pharmaceuticals, 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 1986-10-10.
- Submission: K854236
- Applicant / Sponsor: Nms Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1986-10-10
Classification & Regulation
This clearance is catalogued under FDA product code IAF and 21 CFR 864.1850, within the Hematology review panel as a Class I device.