Clearance Summary
I.V. STRIP received FDA 510(k) clearance under submission number K792049, sponsored by E-Med Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1979-11-20.
- Submission: K792049
- Applicant / Sponsor: E-Med Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1979-11-20
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.