CFJ · Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Clinical Chemistry · 21 CFR 862.1440 · Class 2
Overview
| Product Code | CFJ |
|---|---|
| Device Name | Nad Reduction/Nadh Oxidation, 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 (20 of 111)
Showing 20 most recent of 111 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Oct 2, 2013 | SESE |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Alfa Wassermann, Inc. | Sep 9, 2009 | SESE |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Abaxis, Inc. | Jul 8, 2005 | SESE |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | Diagnostic Chemicals , Ltd. | Jan 22, 1998 | SESE |
| K973589 | LIQUID LDH-L REAGENT SET | Pointe Scientific, Inc., | Oct 8, 1997 | SESE |
| K970684 | LACTATE DEHYDROGENASE (LD) | Randox Laboratories, Ltd. | May 7, 1997 | SESE |
| K971398 | LD-L REAGENT | Carolina Liquid Chemistries Corp. | May 2, 1997 | SESE |
| K964912 | LACTATE DEHYDROGENASE | Derma Media Lab., Inc. | Jan 9, 1997 | SESE |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | Pointe Scientific, Inc., | Jun 3, 1996 | SESE |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | Aug 7, 1995 | SESE |
| K946022 | HICHEM LDH/L REAGENT KIT | Hichem Diagnostics | Feb 23, 1995 | SESE |
| K942964 | LACTATE DEHYDROGENASE QVET | Prisma Systems | Dec 29, 1994 | SESE |
| K935175 | LACTATE DEHYDROGENASE (LD) | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Em Diagnostic Systems, Inc. | Feb 5, 1993 | SESE |
| K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | Nov 16, 1992 | SESE |
| K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | Sep 18, 1992 | SESE |
| K921025 | SYNERMED LDHH-L REAGENT KIT | Synermed, Inc. | Mar 23, 1992 | SESE |
| K915803 | DMA LD KINETIC PROCEDURE | Data Medical Associates, Inc. | Mar 18, 1992 | SESE |
| K914262 | ABBOTT QUICKSTART LDH,#5A31 | Em Diagnostic Systems, Inc. | Oct 11, 1991 | SESE |
| K910640 | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 | Em Diagnostic Systems, Inc. | Apr 12, 1991 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Beckman Instruments, Inc. — 4 clearances
- Harleco — 4 clearances
- J.T. Baker Chemical Co. — 4 clearances
- Boehringer Mannheim Corp. — 3 clearances
