Clearance Summary
IN VITRO 2.5X ROLLER BOTTLE received FDA 510(k) clearance under submission number K873137, sponsored by In Vitro Scientific Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1987-08-24.
- Submission: K873137
- Applicant / Sponsor: In Vitro Scientific Products
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1987-08-24
Classification & Regulation
This clearance is catalogued under FDA product code KJC and 21 CFR 864.2240, within the Hematology review panel as a Class I device.