Clearance Summary
ESENSOR RESPIRATORY VIRAL PANEL received FDA 510(k) clearance under submission number K113731, sponsored by Clinical Micro Sensors, Inc.. 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 2012-09-10.
- Submission: K113731
- Applicant / Sponsor: Clinical Micro Sensors, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2310
- Decision date: 2012-09-10
Classification & Regulation
This clearance is catalogued under FDA product code JJH and 21 CFR 862.2310, within the Clinical Chemistry review panel as a Class I device.