Clearance Summary
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 received FDA 510(k) clearance under submission number K030860, sponsored by Monobind. 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 2003-08-22.
- Submission: K030860
- Applicant / Sponsor: Monobind
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 2003-08-22
Classification & Regulation
This clearance is catalogued under FDA product code KLI and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.