Clearance Summary
SKORE (Colors & Flavors), SKORE (Colors) received FDA 510(k) clearance under submission number K202403, sponsored by Ttk Healthcare Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2021-04-15.
- Submission: K202403
- Applicant / Sponsor: Ttk Healthcare Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2021-04-15
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.