Clearance Summary
SULFOSALICYLIC ACID, 3% W/V received FDA 510(k) clearance under submission number K842915, sponsored by E K Ind., 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 1984-08-10.
- Submission: K842915
- Applicant / Sponsor: E K Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1645
- Decision date: 1984-08-10
Classification & Regulation
This clearance is catalogued under FDA product code JIQ and 21 CFR 862.1645, within the Clinical Chemistry review panel as a Class I device.