Clearance Summary
GUINEA PIG COMPLEMENT REGULAR received FDA 510(k) clearance under submission number K812370, sponsored by Dutchland Laboratories, 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 1981-09-08.
- Submission: K812370
- Applicant / Sponsor: Dutchland Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4100
- Decision date: 1981-09-08
Classification & Regulation
This clearance is catalogued under FDA product code KTQ and 21 CFR 866.4100, within the Immunology review panel as a Class I device.