Clearance Summary
DONOR HORSE SERUM - STERILE received FDA 510(k) clearance under submission number K812381, sponsored by Dutchland Laboratories, 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 1981-09-08.
- Submission: K812381
- Applicant / Sponsor: Dutchland Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2800
- Decision date: 1981-09-08
Classification & Regulation
This clearance is catalogued under FDA product code KIS and 21 CFR 864.2800, within the Hematology review panel as a Class I device.