Clearance Summary
MDX 2000, DIGITAL ANALYZER received FDA 510(k) clearance under submission number K970824, sponsored by Shotwell & Carr, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-05-30.
- Submission: K970824
- Applicant / Sponsor: Shotwell & Carr, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 1997-05-30
Classification & Regulation
This clearance is catalogued under FDA product code JOY and 21 CFR 864.5260, within the Hematology review panel as a Class II device.