Clearance Summary
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL received FDA 510(k) clearance under submission number K111999, sponsored by Healgen Scientific,, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2012-04-17.
- Submission: K111999
- Applicant / Sponsor: Healgen Scientific,, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2012-04-17
Classification & Regulation
This clearance is catalogued under FDA product code JIO and 21 CFR 864.6550, within the Hematology review panel as a Class II device.