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.
Cleared Devices (111)
| 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 |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Biotrol, USA, Inc. | Mar 11, 1991 | SESE |
| K903773 | SYNERMED LDH REAGENT KIT | Synermed, Inc. | Oct 12, 1990 | SESE |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | American Research Products Co. | Apr 19, 1990 | SESE |
| K900121 | ROCHE REAGENT FOR LDH | Roche Diagnostic Systems, Inc. | Mar 30, 1990 | SESE |
| K897164 | COULTER LD (LDH-L) REAGENT | Coulter Electronics, Inc. | Mar 9, 1990 | SESE |
| K896241 | COBAS READY LDH REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K894482 | LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 | Em Diagnostic Systems, Inc. | Sep 7, 1989 | SESE |
| K884548 | LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 | Em Diagnostic Systems, Inc. | Nov 10, 1988 | SESE |
| K883206 | LACTATE DEHYDROGENASE LDH | Electro-Nucleonics, Inc. | Sep 9, 1988 | SESE |
| K881474 | VISION(R) LDH (LACTATE DEHYDROGENASE) | Abbott Laboratories | Jun 1, 1988 | SESE |
| K880842 | LDH-L REAGENT SET | Tech-Neal Scientific, Inc. | Apr 5, 1988 | SESE |
| K875206 | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 | Diagnostic Chemicals, Ltd. (Usa) | Feb 2, 1988 | SESE |
| K874848 | LACTATE DEHYDROGENASE LDH-L | Tech-Co, Inc. | Dec 18, 1987 | SESE |
| K872030 | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) | Sclavo, Inc. | Jul 7, 1987 | SESE |
| K872010 | MULTICHEM LDH-L REAGENT | Simmler, Inc. | Jun 11, 1987 | SESE |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | Biochemical Trade, Inc. | Jun 3, 1987 | SESE |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Miles Laboratories, Inc. | Apr 14, 1987 | SESE |
| K870401 | WAKO(TM) AUTOKIT LDH | Wako Chemicals USA, Inc. | Mar 6, 1987 | SESE |
| K863068 | LDH S.C.E. | J. D. Assoc. | Dec 10, 1986 | SESE |
| K863255 | LACTATE DEHYDROGENASE(LD) PROCEDURE | Data Medical Associates, Inc. | Oct 3, 1986 | SESE |
| K863477 | EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 | Em Diagnostic Systems, Inc. | Sep 26, 1986 | SESE |
| K863545 | EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 | Em Diagnostic Systems, Inc. | Sep 25, 1986 | SESE |
| K862306 | KING DIAGNOSTICS LDH TEST | King Diagnostics, Inc. | Aug 19, 1986 | SESE |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | Sterling Diagnostics, Inc. | Jul 29, 1986 | SESE |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Hi Chem, Inc. | Jun 13, 1986 | SESE |
| K861662 | LACTATE DEHYDROGENASE (LD) PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE |
| K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE | Hi Chem, Inc. | Apr 28, 1986 | SESE |
| K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. | Catachem, Inc. | Apr 24, 1986 | SESE |
| K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | Apr 7, 1986 | SESE |
| K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | Apr 7, 1986 | SESE |
| K860029 | LDH (OPTIMIZED) REAGENT | Sigma Chemical Co. | Feb 6, 1986 | SESE |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | Technostics Intl. | Jan 21, 1986 | SESE |
| K855159 | LACTIC DEHYDROGENASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| K854585 | ULTRAZYME PLUS & SYSTEMATE LDH | Em Diagnostic Systems, Inc. | Dec 5, 1985 | SESE |
| K852948 | AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI | Amresco, Inc. | Aug 7, 1985 | SESE |
| K851996 | LD-L REAGENT | Alpkem Corp. | May 31, 1985 | SESE |
| K851997 | LD-P REAGENT | Alpkem Corp. | May 30, 1985 | SESE |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | Mar 1, 1985 | SESE |
| K843269 | SYSTEMATE LDH, 67210 | Em Diagnostic Systems, Inc. | Sep 13, 1984 | SESE |
| K842507 | LACTATE DEHYDROGENASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Jul 20, 1984 | SESE |
| K842244 | LACTATE DENYDRO GENASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Jul 18, 1984 | SESE |
| K841917 | SIGMS PROCED. 228 UV LACTATE DEHYDRO | Sigma Diagnostics, Inc. | Jun 14, 1984 | SESE |
| K841703 | TDX REA LDH | Abbott Laboratories | Jun 8, 1984 | SESE |
| K841058 | LDH-UV REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K840006 | KINETIC LDH, A< BLUE 610 METHOD | American Monitor Corp. | Mar 23, 1984 | SESE |
| K832048 | ASTRA SYSTEMS ENZYME MODULE LD-P | Beckman Instruments, Inc. | Jul 19, 1983 | SESE |
| K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- | Reagents Applications, Inc. | Jun 16, 1983 | SESE |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | Sterling Biochemical, Inc. | Jun 16, 1983 | SESE |
| K831353 | ASTRA SYSTEMS ENZYME MODULE | Beckman Instruments, Inc. | Jun 8, 1983 | SESE |
| K823721 | FLOW-PAC LDH REAGENT SET | Amresco, Inc. | Jan 9, 1983 | SESE |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | Biorent Diagnostic, Inc. | Sep 17, 1982 | SESE |
| K822312 | RAICHEM LDH-L REAGENT | Reagents Applications, Inc. | Aug 27, 1982 | SESE |
| K821201 | LDH-UV REAGENT SET | Omega Medical Electronics | Jul 20, 1982 | SESE |
| K821878 | ULTRAZYME PLUS LDH | Harleco Diagnostics | Jul 14, 1982 | SESE |
| K821466 | ULTRAZYME PLUS LDH, #64950,65038&65039 | Emd Chemicals, Inc. | Jun 1, 1982 | SESE |
| K820378 | LD-L TRIS SYSTEM PACK TEST | Boehringer Mannheim Corp. | Mar 8, 1982 | SESE |
| K813496 | LDH-L | Pointe Scientific, Inc., | Dec 31, 1981 | SESE |
| K812590 | ULTRA ZYME PLUS LDH #64950, 65038 & 39 | Harleco | Sep 24, 1981 | SESE |
| K812472 | SPIN-CHEM LD-L REAGENT | Smithkline Diagnostics, Inc. | Sep 14, 1981 | SESE |
| K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT | Bio-Analytics Laboratories, Inc. | Jan 28, 1981 | SESE |
| K803019 | SERALYZER LDH REAGENT STRIPS, CALIBR | Miles Laboratories, Inc. | Dec 22, 1980 | SESE |
| K802572 | BECKMAN LIQUID-STAT LD-L-UV ENZYME | Beckman Instruments, Inc. | Nov 12, 1980 | SESE |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | Diagnostic Solutions, Inc. | May 28, 1980 | SESE |
| K800120 | LDH (L-P) REAGENT | Gilford Diagnostics | Feb 13, 1980 | SESE |
| K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO | Hoffmann-La Roche, Inc. | Jan 17, 1980 | SESE |
| K791085 | PLUS CHEM, DETERMINATION OF LD (LDH-P) | Smithkline Diagnostics, Inc. | Jul 17, 1979 | SESE |
| K791081 | SPIN CHEM REAGENT, DETERMINATION OF LDH- | Smithkline Diagnostics, Inc. | Jul 17, 1979 | SESE |
| K790771 | LD-P REAGENT (LDH P-L REAGENT) | Gilford Diagnostics | May 15, 1979 | SESE |
| K790248 | NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) | Boehringer Laboratories | Apr 4, 1979 | SESE |
| K790020 | SERUM, LACTIC DEHYDROGENASE | Fisher Scientific Co., LLC | Feb 8, 1979 | SESE |
| K781775 | LDH | Gilford Diagnostics | Nov 22, 1978 | SESE |
| K781765 | LDH REAGENT SYSTEM | American Monitor Corp. | Nov 22, 1978 | SESE |
| K781724 | NAD REDUCTION METHOD, LACTATE PYRIVATE | Medical Analysis Systems, Inc. | Nov 3, 1978 | SESE |
| K781538 | SINGLE VIAL LDH-L TRIS | Boehringer Mannheim Corp. | Oct 3, 1978 | SESE |
| K781128 | LDH (UV KINETIC) | Macomb Chemical Co. | Aug 10, 1978 | SESE |
| K780563 | SINGLE VIAL LACTATE | Boehringer Mannheim Corp. | Apr 18, 1978 | SESE |
| K780101 | ULTRAZYME PLUS LDH | Harleco | Feb 14, 1978 | SESE |
| K780041 | LACTATE DEHYDROGENASE | Beckman Instruments, Inc. | Feb 1, 1978 | SESE |
| K771836 | LACTATE DEHYDROGENASE | Gamma Enterprises, Inc. | Nov 22, 1977 | SESE |
| K772028 | GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH | Harleco | Nov 15, 1977 | SESE |
| K771465 | MULTISTAT III LACTIC DEHYDROGENASE | Instrumentation Laboratory CO | Sep 2, 1977 | SESE |
| K770818 | ULTRAZYME PLUS, LDH | Harleco | Jul 11, 1977 | SESE |
| K770613 | LDH ULTRAZYME PLUS | Harleco Diagnostics | Jun 17, 1977 | SESE |
| K770313 | REAGENT LDH-L, ENZYME | Icn Pharmaceuticals, Inc. | Apr 5, 1977 | SESE |
| K770267 | LDH-L TEST | Sclavo, Inc. | Feb 23, 1977 | SESE |
| K761343 | DYNAZYME-II TM LDH-L 340 KIT | J.T. Baker Chemical Co. | Jan 5, 1977 | SESE |
| K760412 | LDH SUBSTRATE | J.T. Baker Chemical Co. | Nov 2, 1976 | SESE |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | Simmler & Son, Inc. | Nov 1, 1976 | SESE |
| K760411 | NAD (SPOONPAK CONTAINER) | J.T. Baker Chemical Co. | Oct 29, 1976 | SESE |
| K760410 | AMP BUFFER | J.T. Baker Chemical Co. | Oct 29, 1976 | SESE |
| K760345 | TEST, LACTATE DEHYDROGENASE | Princeton Biomedix | Oct 27, 1976 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- J.T. Baker Chemical Co. — 4 clearances
- Harleco — 4 clearances
- Beckman Instruments, Inc. — 4 clearances
- Smithkline Diagnostics, Inc. — 3 clearances
