MODIFIED INTENDED USE OF CLEANING REAGENT KIT
Device Facts
| Record ID | K890184 |
|---|---|
| Device Name | MODIFIED INTENDED USE OF CLEANING REAGENT KIT |
| Applicant | Hichem Diagnostics |
| Product Code | JJE · Clinical Chemistry |
| Decision Date | Feb 7, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
