Clearance Summary
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL received FDA 510(k) clearance under submission number K022085, sponsored by J & S Medical Assoc., 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 2002-07-25.
- Submission: K022085
- Applicant / Sponsor: J & S Medical Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2002-07-25
Classification & Regulation
This clearance is catalogued under FDA product code JJW and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.