Product code CFJ— Clinical Chemistry
LACTATE DEHYDROGENASE
- Classification name
- Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Total cleared
- 111
- First cleared
- Most recent
Market context for product code CFJ
FDA has cleared devices under product code CFJ between 1976 and 2013, filed by 67 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2013
- 2009
- 2005
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
Top applicants under product code CFJ
Recent clearances under product code CFJ
1–100 of 111- K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
- K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
- K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
- K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
- K973589 — LIQUID LDH-L REAGENT SET
- K970684 — LACTATE DEHYDROGENASE (LD)
- K971398 — LD-L REAGENT
- K964912 — LACTATE DEHYDROGENASE
- K961431 — LACTATE DEHYDROGENASE REAGENT SET
- K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM
- K946022 — HICHEM LDH/L REAGENT KIT
- K942964 — LACTATE DEHYDROGENASE QVET
- K935175 — LACTATE DEHYDROGENASE (LD)
- K924703 — LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
- K924965 — OLYMPUS LACTATE DEHYDROGENASE REAGENT
- K923412 — OLYMPUS LACTATE DEHYDROGENASE REAGENT
- K921025 — SYNERMED LDHH-L REAGENT KIT
- K915803 — DMA LD KINETIC PROCEDURE
- K914262 — ABBOTT QUICKSTART LDH,#5A31
- K910640 — SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
- K905683 — BIOTROL LACTATE DEHYDROGENASE (L-P)
- K903773 — SYNERMED LDH REAGENT KIT
- K900667 — AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
- K900121 — ROCHE REAGENT FOR LDH
- K897164 — COULTER LD (LDH-L) REAGENT
- K896241 — COBAS READY LDH REAGENT
- K894482 — LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
- K884548 — LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
- K883206 — LACTATE DEHYDROGENASE LDH
- K881474 — VISION(R) LDH (LACTATE DEHYDROGENASE)
- K880842 — LDH-L REAGENT SET
- K875206 — LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
- K874848 — LACTATE DEHYDROGENASE LDH-L
- K872030 — UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
- K872010 — MULTICHEM LDH-L REAGENT
- K871781 — ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
- K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
- K870401 — WAKO(TM) AUTOKIT LDH
- K863068 — LDH S.C.E.
- K863255 — LACTATE DEHYDROGENASE(LD) PROCEDURE
- K863477 — EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
- K863545 — EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
- K862306 — KING DIAGNOSTICS LDH TEST
- K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
- K862027 — LDP REAGENT CARTRIDGE (NO. 88216)
- K861662 — LACTATE DEHYDROGENASE (LD) PROCEDURE
- K861419 — HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
- K860713 — LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
- K860728 — L D H-L (LACTIC DEHYDROGENASE) REAGENT
- K860729 — LDH-P (LACTIC DEHYDROGENASE) REAGENT
- K860029 — LDH (OPTIMIZED) REAGENT
- K855157 — LACTIC DEHYDROGENASE (VV) REAGENT SET
- K855159 — LACTIC DEHYDROGENASE REAGENT SET
- K854585 — ULTRAZYME PLUS & SYSTEMATE LDH
- K852948 — AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
- K851996 — LD-L REAGENT
- K851997 — LD-P REAGENT
- K850378 — LDH REAGENT FOR DEMAND ANALYZER
- K843269 — SYSTEMATE LDH, 67210
- K842507 — LACTATE DEHYDROGENASE ASSAY KIT
- K842244 — LACTATE DENYDRO GENASE ASSAY KIT
- K841917 — SIGMS PROCED. 228 UV LACTATE DEHYDRO
- K841703 — TDX REA LDH
- K841058 — LDH-UV REAGENT SET
- K840006 — KINETIC LDH, A< BLUE 610 METHOD
- K832048 — ASTRA SYSTEMS ENZYME MODULE LD-P
- K831415 — LACTIC DEHYDROGENASE REAGENT SET
- K831419 — RAICHEM LDH-P REAGENT W/SEPARATE START-
- K831353 — ASTRA SYSTEMS ENZYME MODULE
- K823721 — FLOW-PAC LDH REAGENT SET
- K822492 — OPTIMIZED UV-LDH REAGENT SET
- K822312 — RAICHEM LDH-L REAGENT
- K821201 — LDH-UV REAGENT SET
- K821878 — ULTRAZYME PLUS LDH
- K821466 — ULTRAZYME PLUS LDH, #64950,65038&65039
- K820378 — LD-L TRIS SYSTEM PACK TEST
- K813496 — LDH-L
- K812590 — ULTRA ZYME PLUS LDH #64950, 65038 & 39
- K812472 — SPIN-CHEM LD-L REAGENT
- K810083 — LDH-L LIQUID ENZYMATIC, KINETIC KIT
- K803019 — SERALYZER LDH REAGENT STRIPS, CALIBR
- K802572 — BECKMAN LIQUID-STAT LD-L-UV ENZYME
- K800691 — REAGENT FOR DETERM. LACTATE/DEHYDROGENAS
- K800120 — LDH (L-P) REAGENT
- K792658 — COBAS-BLO REAGENTS (LACTATE DEHYDRO
- K791081 — SPIN CHEM REAGENT, DETERMINATION OF LDH-
- K791085 — PLUS CHEM, DETERMINATION OF LD (LDH-P)
- K790771 — LD-P REAGENT (LDH P-L REAGENT)
- K790248 — NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
- K790020 — SERUM, LACTIC DEHYDROGENASE
- K781765 — LDH REAGENT SYSTEM
- K781775 — LDH
- K781724 — NAD REDUCTION METHOD, LACTATE PYRIVATE
- K781538 — SINGLE VIAL LDH-L TRIS
- K781128 — LDH (UV KINETIC)
- K780563 — SINGLE VIAL LACTATE
- K780101 — ULTRAZYME PLUS LDH
- K780041 — LACTATE DEHYDROGENASE
- K771836 — LACTATE DEHYDROGENASE
- K772028 — GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
Data sourced from openFDA. This site is unofficial and independent of the FDA.