Product Code: CFJ
FDA class 2
21 CFR 862.1440
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Clinical Chemistry
The NAD Reduction/NADH Oxidation Lactate Dehydrogenase Test is a clinical chemistry device that measures LDH enzyme activity by monitoring the reduction of NAD+ to NADH (or reverse) spectrophotometrically, providing a kinetic measure of LDH used in the evaluation of myocardial infarction, liver disease, and other conditions associated with tissue necrosis. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CFJ, regulated under 21 CFR 862.1440, within the Clinical Chemistry medical specialty. No special flags apply to this device.
510(k)s
111
FEI Numbers
46
Registration Numbers
46
Unique Applicants
67
Years Active
37
Basic Information
- Product Code
- CFJ
- Device Class
- FDA class 2
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 111 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | Oct 02, 2013 | Substantially Equivalent | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Sep 09, 2009 | Substantially Equivalent | ALFA WASSERMANN, INC. |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Jul 08, 2005 | Substantially Equivalent | ABAXIS, INC. |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | Jan 22, 1998 | Substantially Equivalent | DIAGNOSTIC CHEMICALS LTD. |
| K973589 | LIQUID LDH-L REAGENT SET | Oct 08, 1997 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K970684 | LACTATE DEHYDROGENASE (LD) | May 07, 1997 | Substantially Equivalent | RANDOX LABORATORIES, LTD. |
| K971398 | LD-L REAGENT | May 02, 1997 | Substantially Equivalent | CAROLINA LIQUID CHEMISTRIES CORP. |
| K964912 | LACTATE DEHYDROGENASE | Jan 09, 1997 | Substantially Equivalent | DERMA MEDIA LAB., INC. |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | Jun 03, 1996 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Aug 07, 1995 | Substantially Equivalent | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
| K946022 | HICHEM LDH/L REAGENT KIT | Feb 23, 1995 | Substantially Equivalent | HICHEM DIAGNOSTICS |
| K942964 | LACTATE DEHYDROGENASE QVET | Dec 29, 1994 | Substantially Equivalent | PRISMA SYSTEMS |
| K935175 | LACTATE DEHYDROGENASE (LD) | Dec 16, 1993 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Feb 05, 1993 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Nov 16, 1992 | Substantially Equivalent | OLYMPUS CORP. |
| K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Sep 18, 1992 | Substantially Equivalent | OLYMPUS CORP. |
| K921025 | SYNERMED LDHH-L REAGENT KIT | Mar 23, 1992 | Substantially Equivalent | SYNERMED, INC. |
| K915803 | DMA LD KINETIC PROCEDURE | Mar 18, 1992 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K914262 | ABBOTT QUICKSTART LDH,#5A31 | Oct 11, 1991 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K910640 | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 | Apr 12, 1991 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Mar 11, 1991 | Substantially Equivalent | BIOTROL, USA, INC. |
| K903773 | SYNERMED LDH REAGENT KIT | Oct 12, 1990 | Substantially Equivalent | SYNERMED, INC. |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | Apr 19, 1990 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K900121 | ROCHE REAGENT FOR LDH | Mar 30, 1990 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K897164 | COULTER LD (LDH-L) REAGENT | Mar 09, 1990 | Substantially Equivalent | COULTER ELECTRONICS, INC. |
| K896241 | COBAS READY LDH REAGENT | Feb 16, 1990 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K894482 | LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 | Sep 07, 1989 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K884548 | LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 | Nov 10, 1988 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K883206 | LACTATE DEHYDROGENASE LDH | Sep 09, 1988 | Substantially Equivalent | ELECTRO-NUCLEONICS, INC. |
| K881474 | VISION(R) LDH (LACTATE DEHYDROGENASE) | Jun 01, 1988 | Substantially Equivalent | ABBOTT LABORATORIES |
| K880842 | LDH-L REAGENT SET | Apr 05, 1988 | Substantially Equivalent | TECH-NEAL SCIENTIFIC, INC. |
| K875206 | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 | Feb 02, 1988 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K874848 | LACTATE DEHYDROGENASE LDH-L | Dec 18, 1987 | Substantially Equivalent | TECH-CO, INC. |
| K872030 | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) | Jul 07, 1987 | Substantially Equivalent | SCLAVO, INC. |
| K872010 | MULTICHEM LDH-L REAGENT | Jun 11, 1987 | Substantially Equivalent | SIMMLER, INC. |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | Jun 03, 1987 | Substantially Equivalent | BIOCHEMICAL TRADE, INC. |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 1987 | Substantially Equivalent | MILES LABORATORIES, INC. |
| K870401 | WAKO(TM) AUTOKIT LDH | Mar 06, 1987 | Substantially Equivalent | WAKO CHEMICALS, USA, INC. |
| K863068 | LDH S.C.E. | Dec 10, 1986 | Substantially Equivalent | J. D. ASSOC. |
| K863255 | LACTATE DEHYDROGENASE(LD) PROCEDURE | Oct 03, 1986 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K863477 | EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 | Sep 26, 1986 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K863545 | EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 | Sep 25, 1986 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K862306 | KING DIAGNOSTICS LDH TEST | Aug 19, 1986 | Substantially Equivalent | KING DIAGNOSTICS, INC. |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | Jul 29, 1986 | Substantially Equivalent | STERLING DIAGNOSTICS, INC. |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Jun 13, 1986 | Substantially Equivalent | HI CHEM, INC. |
| K861662 | LACTATE DEHYDROGENASE (LD) PROCEDURE | May 29, 1986 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE | Apr 28, 1986 | Substantially Equivalent | HI CHEM, INC. |
| K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. | Apr 24, 1986 | Substantially Equivalent | CATACHEM, INC. |
| K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT | Apr 07, 1986 | Substantially Equivalent | TRACE SCIENTIFIC LTD. |
| K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT | Apr 07, 1986 | Substantially Equivalent | TRACE SCIENTIFIC LTD. |
| K860029 | LDH (OPTIMIZED) REAGENT | Feb 06, 1986 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | Jan 21, 1986 | Substantially Equivalent | TECHNOSTICS INTL. |
| K855159 | LACTIC DEHYDROGENASE REAGENT SET | Jan 14, 1986 | Substantially Equivalent | TECHNOSTICS INTL. |
| K854585 | ULTRAZYME PLUS & SYSTEMATE LDH | Dec 05, 1985 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K852948 | AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI | Aug 07, 1985 | Substantially Equivalent | AMRESCO, INC. |
| K851996 | LD-L REAGENT | May 31, 1985 | Substantially Equivalent | ALPKEM CORP. |
| K851997 | LD-P REAGENT | May 30, 1985 | Substantially Equivalent | ALPKEM CORP. |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Mar 01, 1985 | Substantially Equivalent | ADVANCED BIOMEDICAL METHODS, INC. |
| K843269 | SYSTEMATE LDH, 67210 | Sep 13, 1984 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K842507 | LACTATE DEHYDROGENASE ASSAY KIT | Jul 20, 1984 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K842244 | LACTATE DENYDRO GENASE ASSAY KIT | Jul 18, 1984 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K841917 | SIGMS PROCED. 228 UV LACTATE DEHYDRO | Jun 14, 1984 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K841703 | TDX REA LDH | Jun 08, 1984 | Substantially Equivalent | ABBOTT LABORATORIES |
| K841058 | LDH-UV REAGENT SET | May 01, 1984 | Substantially Equivalent | MEDICAL SPECIALTIES, INC. |
| K840006 | KINETIC LDH, A< BLUE 610 METHOD | Mar 23, 1984 | Substantially Equivalent | AMERICAN MONITOR CORP. |
| K832048 | ASTRA SYSTEMS ENZYME MODULE LD-P | Jul 19, 1983 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- | Jun 16, 1983 | Substantially Equivalent | REAGENTS APPLICATIONS, INC. |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | Jun 16, 1983 | Substantially Equivalent | STERLING BIOCHEMICAL, INC. |
| K831353 | ASTRA SYSTEMS ENZYME MODULE | Jun 08, 1983 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K823721 | FLOW-PAC LDH REAGENT SET | Jan 09, 1983 | Substantially Equivalent | AMRESCO, INC. |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | Sep 17, 1982 | Substantially Equivalent | BIORENT DIAGNOSTIC, INC. |
| K822312 | RAICHEM LDH-L REAGENT | Aug 27, 1982 | Substantially Equivalent | REAGENTS APPLICATIONS, INC. |
| K821201 | LDH-UV REAGENT SET | Jul 20, 1982 | Substantially Equivalent | OMEGA MEDICAL ELECTRONICS |
| K821878 | ULTRAZYME PLUS LDH | Jul 14, 1982 | Substantially Equivalent | HARLECO DIAGNOSTICS |
| K821466 | ULTRAZYME PLUS LDH, #64950,65038&65039 | Jun 01, 1982 | Substantially Equivalent | EMD CHEMICALS INC. |
| K820378 | LD-L TRIS SYSTEM PACK TEST | Mar 08, 1982 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K813496 | LDH-L | Dec 31, 1981 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K812590 | ULTRA ZYME PLUS LDH #64950, 65038 & 39 | Sep 24, 1981 | Substantially Equivalent | HARLECO |
| K812472 | SPIN-CHEM LD-L REAGENT | Sep 14, 1981 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT | Jan 28, 1981 | Substantially Equivalent | BIO-ANALYTICS LABORATORIES, INC. |
| K803019 | SERALYZER LDH REAGENT STRIPS, CALIBR | Dec 22, 1980 | Substantially Equivalent | MILES LABORATORIES, INC. |
| K802572 | BECKMAN LIQUID-STAT LD-L-UV ENZYME | Nov 12, 1980 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | May 28, 1980 | Substantially Equivalent | DIAGNOSTIC SOLUTIONS, INC. |
| K800120 | LDH (L-P) REAGENT | Feb 13, 1980 | Substantially Equivalent | GILFORD DIAGNOSTICS |
| K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO | Jan 17, 1980 | Substantially Equivalent | HOFFMANN-LA ROCHE, INC. |
| K791085 | PLUS CHEM, DETERMINATION OF LD (LDH-P) | Jul 17, 1979 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K791081 | SPIN CHEM REAGENT, DETERMINATION OF LDH- | Jul 17, 1979 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K790771 | LD-P REAGENT (LDH P-L REAGENT) | May 15, 1979 | Substantially Equivalent | GILFORD DIAGNOSTICS |
| K790248 | NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) | Apr 04, 1979 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K790020 | SERUM, LACTIC DEHYDROGENASE | Feb 08, 1979 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K781775 | LDH | Nov 22, 1978 | Substantially Equivalent | GILFORD DIAGNOSTICS |
| K781765 | LDH REAGENT SYSTEM | Nov 22, 1978 | Substantially Equivalent | AMERICAN MONITOR CORP. |
| K781724 | NAD REDUCTION METHOD, LACTATE PYRIVATE | Nov 03, 1978 | Substantially Equivalent | MEDICAL ANALYSIS SYSTEMS, INC. |
| K781538 | SINGLE VIAL LDH-L TRIS | Oct 03, 1978 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K781128 | LDH (UV KINETIC) | Aug 10, 1978 | Substantially Equivalent | MACOMB CHEMICAL CO. |
| K780563 | SINGLE VIAL LACTATE | Apr 18, 1978 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K780101 | ULTRAZYME PLUS LDH | Feb 14, 1978 | Substantially Equivalent | HARLECO |
| K780041 | LACTATE DEHYDROGENASE | Feb 01, 1978 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K771836 | LACTATE DEHYDROGENASE | Nov 22, 1977 | Substantially Equivalent | GAMMA ENTERPRISES, INC. |
| K772028 | GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH | Nov 15, 1977 | Substantially Equivalent | HARLECO |
| K771465 | MULTISTAT III LACTIC DEHYDROGENASE | Sep 02, 1977 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K770818 | ULTRAZYME PLUS, LDH | Jul 11, 1977 | Substantially Equivalent | HARLECO |
| K770613 | LDH ULTRAZYME PLUS | Jun 17, 1977 | Substantially Equivalent | HARLECO DIAGNOSTICS |
| K770313 | REAGENT LDH-L, ENZYME | Apr 05, 1977 | Substantially Equivalent | ICN PHARMACEUTICALS, INC. |
| K770267 | LDH-L TEST | Feb 23, 1977 | Substantially Equivalent | SCLAVO, INC. |
| K761343 | DYNAZYME-II TM LDH-L 340 KIT | Jan 05, 1977 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K760412 | LDH SUBSTRATE | Nov 02, 1976 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | Nov 01, 1976 | Substantially Equivalent | SIMMLER & SON, INC. |
| K760411 | NAD (SPOONPAK CONTAINER) | Oct 29, 1976 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K760410 | AMP BUFFER | Oct 29, 1976 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K760345 | TEST, LACTATE DEHYDROGENASE | Oct 27, 1976 | Substantially Equivalent | PRINCETON BIOMEDIX |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.