Clearance Summary
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance under submission number K070531, sponsored by Thermo Fisher Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2007-09-04.
- Submission: K070531
- Applicant / Sponsor: Thermo Fisher Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1170
- Decision date: 2007-09-04
Classification & Regulation
This clearance is catalogued under FDA product code CGZ and 21 CFR 862.1170, within the Clinical Chemistry review panel as a Class II device.