ANALYZER, IMPACT 100
Device Facts
| Record ID | K790073 |
|---|---|
| Device Name | ANALYZER, IMPACT 100 |
| Applicant | Gilford Instrument Laboratories, Inc. |
| Product Code | JJI · Clinical Chemistry |
| Decision Date | Feb 22, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.
