Clearance Summary
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 received FDA 510(k) clearance under submission number K883451, sponsored by J R Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1988-08-30.
- Submission: K883451
- Applicant / Sponsor: J R Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2220
- Decision date: 1988-08-30
Classification & Regulation
This clearance is catalogued under FDA product code KIT and 21 CFR 864.2220, within the Hematology review panel as a Class I device.