ISO-SEP SYSTEM
Device Facts
| Record ID | K842018 |
|---|---|
| Device Name | ISO-SEP SYSTEM |
| Applicant | Berwick Medical Products, Inc. |
| Product Code | CEX · Clinical Chemistry |
| Decision Date | Sep 28, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1445 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
