CFH · Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Clinical Chemistry · 21 CFR 862.1440 · Class 2
Overview
| Product Code | CFH |
|---|---|
| Device Name | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase |
| Regulation | 21 CFR 862.1440 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
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 § 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 § 862.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050790 | SPOTCHEM II LDH TEST | Arkray, Inc. | Jun 6, 2005 | SESE |
| K020484 | CARESIDE LDH | Careside, Inc. | Jul 3, 2002 | SESE |
| K895138 | CLINISTAT LDH REAGENT TEST | Heraeus Kulzer, Inc. | Oct 19, 1989 | SESE |
| K894578 | IQ LDH | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 17, 1989 | SESE |
| K880630 | LACTATE DEHYDROGENASE (LDH-L) | Tech-Co, Inc. | Mar 16, 1988 | SESE |
| K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET | Sterling Diagnostics, Inc. | Feb 28, 1986 | SESE |
| K852391 | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE | Helena Laboratories | Oct 1, 1985 | SESE |
| K842452 | WAKO LDH CII TEST | Wako Chemicals USA, Inc. | Aug 15, 1984 | SESE |
| K820768 | COLORIMETRIC LDH REAGENT SET | Biorent Diagnostic, Inc. | Apr 14, 1982 | SESE |
| K812836 | LDH REAGENT SET | Anco Medical Reagents & Assoc. | Oct 9, 1981 | SESP |
| K782176 | HYCEL LDH-INT TEST | Hycel, Inc. | Jan 26, 1979 | SESE |
| K771343 | LDH-INT TEST | Hycel, Inc. | Aug 10, 1977 | SESE |
| K760009 | COLORIMETRIC DETERMINATION (LDH) | The Dow Chemical Co. | Jul 20, 1976 | SESE |
Top Applicants
- Hycel, Inc. — 2 clearances
- Anco Medical Reagents & Assoc. — 1 clearance
- Arkray, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biorent Diagnostic, Inc. — 1 clearance
