Clearance Summary
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA received FDA 510(k) clearance under submission number K950308, sponsored by Solarcare Technologies Corp,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1995-04-14.
- Submission: K950308
- Applicant / Sponsor: Solarcare Technologies Corp,Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3540
- Decision date: 1995-04-14
Classification & Regulation
This clearance is catalogued under FDA product code JXS and 21 CFR 874.3540, within the Ear, Nose, Throat review panel as a Class I device.