Clearance Summary
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER received FDA 510(k) clearance under submission number K993375, sponsored by Clinical Diagnostic Solutions, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1999-12-20.
- Submission: K993375
- Applicant / Sponsor: Clinical Diagnostic Solutions, Inc.
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8150
- Decision date: 1999-12-20
Classification & Regulation
This clearance is catalogued under FDA product code KRX and 21 CFR 864.8150, within the Hematology review panel as a Class II device.