CEX · Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Clinical Chemistry · 21 CFR 862.1445 · Class 2
Overview
| Product Code | CEX |
|---|---|
| Device Name | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| Regulation | 21 CFR 862.1445 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872891 | LACTATE DEHYDROGENASE ISOENZYME 1 | Data Medical Associates, Inc. | Sep 16, 1987 | SESE |
| K851521 | LD-1(IMMUNO) SEPARATION SET | Seragen Diagnostics, Inc. | May 10, 1985 | SESE |
| K842018 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | Sep 28, 1984 | SESE |
| K821983 | TITAN GEL LDH ISOENZYME KIT | Helena Laboratories | Dec 22, 1982 | SESE |
| K821879 | ULTRACHEM T.P. | Harleco Diagnostics | Jul 14, 1982 | SESE |
| K800129 | CENTRIFICHEM CREATININE | Union Carbide Corp. | Feb 13, 1980 | SESE |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | Worthington Biochemical Corp. | Jan 24, 1978 | SESE |
| K771894 | LDH ISOENZYME CONTROL | Bio-Reagents & Diagnostics, Inc. | Dec 22, 1977 | SESE |
Top Applicants
- Berwick Medical Products, Inc. — 1 clearance
- Bio-Reagents & Diagnostics, Inc. — 1 clearance
- Data Medical Associates, Inc. — 1 clearance
- Harleco Diagnostics — 1 clearance
- Helena Laboratories — 1 clearance
