ARRAY(R) 360
Device Facts
| Record ID | K922273 |
|---|---|
| Device Name | ARRAY(R) 360 |
| Applicant | Beckman Instruments, Inc. |
| Product Code | JQX · Clinical Chemistry |
| Decision Date | Aug 19, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.
