Clearance Summary
HERPES-IHA KIT received FDA 510(k) clearance under submission number K822095, sponsored by Hillcrest Biologicals. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-04-05.
- Submission: K822095
- Applicant / Sponsor: Hillcrest Biologicals
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1983-04-05
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.