Clearance Summary
KEMBLE LIQUID HANDLING SYSTEM DISPENSER received FDA 510(k) clearance under submission number K896684, sponsored by Schiff & Co.. 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 1990-04-16.
- Submission: K896684
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 1990-04-16
Classification & Regulation
This clearance is catalogued under FDA product code JQW and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.