FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves whether the Direct TIBC Calibrator Set meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance study details, acceptance criteria, or performance data.

Ask a Question

Ask a specific question about this device

K Number

K000783

Device Name

DIRECT TIBC CALIBRATOR

Manufacturer

REFERENCE DIAGNOSTICS, INC.

Date Cleared

2000-05-04

(55 days)

Product Code