Clearance Summary
NSI LYSING-D REAGENT -4000 ML received FDA 510(k) clearance under submission number K850944, sponsored by Nobel Scientific Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-03-29.
- Submission: K850944
- Applicant / Sponsor: Nobel Scientific Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8540
- Decision date: 1985-03-29
Classification & Regulation
This clearance is catalogued under FDA product code GGK and 21 CFR 864.8540, within the Hematology review panel as a Class I device.