AMES/GILFORD OPTIMATE CLIN. CHEM & THER
Device Facts
| Record ID | K821583 |
|---|---|
| Device Name | AMES/GILFORD OPTIMATE CLIN. CHEM & THER |
| Applicant | Gilford Instrument Laboratories, Inc. |
| Product Code | JJF · Clinical Chemistry |
| Decision Date | Jun 24, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2170 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A micro 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. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
