DIRECT TIBC CALIBRATOR
Device Facts
| Record ID | K000783 |
|---|---|
| Device Name | DIRECT TIBC CALIBRATOR |
| Applicant | Reference Diagnostics, Inc. |
| Product Code | JIT · Clinical Chemistry |
| Decision Date | May 4, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
