AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
Device Facts
| Record ID | K930489 |
|---|---|
| Device Name | AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | JJE · Clinical Chemistry |
| Decision Date | May 12, 1993 |
| 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.
