Clearance Summary
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST received FDA 510(k) clearance under submission number K121231, sponsored by Ind Ndiagnostic, Inc.. 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 2012-07-30.
- Submission: K121231
- Applicant / Sponsor: Ind Ndiagnostic, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2012-07-30
Classification & Regulation
This clearance is catalogued under FDA product code NGT and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.