ELECSYS CA 125 II CALSET
Device Facts
| Record ID | K003969 |
|---|---|
| Device Name | ELECSYS CA 125 II CALSET |
| Applicant | Roche Diagnostics Corp. |
| Product Code | JIS · Clinical Chemistry |
| Decision Date | Jan 12, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
