Clearance Summary
IMAGEN CHLAMYDIA TEST received FDA 510(k) clearance under submission number K844683, sponsored by Boots-Celltech Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-02-06.
- Submission: K844683
- Applicant / Sponsor: Boots-Celltech Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1985-02-06
Classification & Regulation
This clearance is catalogued under FDA product code IWP and 21 CFR 892.6500, within the Radiology review panel as a Class I device.