Clearance Summary
ELECSYS HSV-2 IGG IMMUNOASSAY received FDA 510(k) clearance under submission number K121895, sponsored by Roche Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2012-08-24.
- Submission: K121895
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2012-08-24
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.