Clearance Summary
PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU received FDA 510(k) clearance under submission number K821019, sponsored by Microbiological Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1982-04-26.
- Submission: K821019
- Applicant / Sponsor: Microbiological Research Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1982-04-26
Classification & Regulation
This clearance is catalogued under FDA product code LEB and 21 CFR 864.4010, within the Pathology review panel as a Class I device.