MINISTAT-S CHEMISTRY ANALYZER
Device Facts
| Record ID | K771591 |
|---|---|
| Device Name | MINISTAT-S CHEMISTRY ANALYZER |
| Applicant | Biokinetix Corp. |
| Product Code | JJI · Clinical Chemistry |
| Decision Date | Sep 20, 1977 |
| 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.
