Clearance Summary
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE received FDA 510(k) clearance under submission number K971508, sponsored by Bio-Whittaker, Inc., A Cambrex Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-09-17.
- Submission: K971508
- Applicant / Sponsor: Bio-Whittaker, Inc., A Cambrex Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2280
- Decision date: 1997-09-17
Classification & Regulation
This clearance is catalogued under FDA product code KIR and 21 CFR 864.2280, within the Hematology review panel as a Class I device.