Atlas FDA

CFJ

111 FDA 510(k) clearances · Product code

37 daysmedian time to decision
81 days90th percentile
111clearances measured

FDA profile

Official device name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1440
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2010: 4 · 2017: 15 · 2019: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT (K131975)Alfa Wassermann Diagnostic Technologies, Inc.2013-10-02
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (K091544)Alfa Wassermann, Inc.2009-09-09
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (K051108)Abaxis, Inc.2005-07-08
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (K974859)Diagnostic Chemicals , Ltd.1998-01-22
LIQUID LDH-L REAGENT SET (K973589)Pointe Scientific, Inc.,1997-10-08
LACTATE DEHYDROGENASE (LD) (K970684)Randox Laboratories, Ltd.1997-05-07
LD-L REAGENT (K971398)Carolina Liquid Chemistries Corp.1997-05-02
LACTATE DEHYDROGENASE (K964912)Derma Media Lab., Inc.1997-01-09
LACTATE DEHYDROGENASE REAGENT SET (K961431)Pointe Scientific, Inc.,1996-06-03
LACTATE DEHYDROGENASE REAGENT SYSTEM (K952747)Medical Diagnostic Technologies, Inc.1995-08-07
HICHEM LDH/L REAGENT KIT (K946022)Hichem Diagnostics1995-02-23
LACTATE DEHYDROGENASE QVET (K942964)Prisma Systems1994-12-29
LACTATE DEHYDROGENASE (LD) (K935175)Em Diagnostic Systems, Inc.1993-12-16
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 (K924703)Em Diagnostic Systems, Inc.1993-02-05
OLYMPUS LACTATE DEHYDROGENASE REAGENT (K924965)Olympus Corp.1992-11-16
OLYMPUS LACTATE DEHYDROGENASE REAGENT (K923412)Olympus Corp.1992-09-18
SYNERMED LDHH-L REAGENT KIT (K921025)Synermed, Inc.1992-03-23
DMA LD KINETIC PROCEDURE (K915803)Data Medical Associates, Inc.1992-03-18
ABBOTT QUICKSTART LDH,#5A31 (K914262)Em Diagnostic Systems, Inc.1991-10-11
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 (K910640)Em Diagnostic Systems, Inc.1991-04-12
BIOTROL LACTATE DEHYDROGENASE (L-P) (K905683)Biotrol, USA, Inc.1991-03-11
SYNERMED LDH REAGENT KIT (K903773)Synermed, Inc.1990-10-12
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 (K900667)American Research Products Co.1990-04-19
ROCHE REAGENT FOR LDH (K900121)Roche Diagnostic Systems, Inc.1990-03-30
COULTER LD (LDH-L) REAGENT (K897164)Coulter Electronics, Inc.1990-03-09
COBAS READY LDH REAGENT (K896241)Roche Diagnostic Systems, Inc.1990-02-16
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 (K894482)Em Diagnostic Systems, Inc.1989-09-07
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 (K884548)Em Diagnostic Systems, Inc.1988-11-10
LACTATE DEHYDROGENASE LDH (K883206)Electro-Nucleonics, Inc.1988-09-09
VISION(R) LDH (LACTATE DEHYDROGENASE) (K881474)Abbott Laboratories1988-06-01
LDH-L REAGENT SET (K880842)Tech-Neal Scientific, Inc.1988-04-05
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 (K875206)Diagnostic Chemicals, Ltd. (Usa)1988-02-02
LACTATE DEHYDROGENASE LDH-L (K874848)Tech-Co, Inc.1987-12-18
UNI-FAST LACTATE DEHYDROGENASE (LDH-L) (K872030)Sclavo, Inc.1987-07-07
MULTICHEM LDH-L REAGENT (K872010)Simmler, Inc.1987-06-11
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET (K871781)Biochemical Trade, Inc.1987-06-03
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (K870752)Miles Laboratories, Inc.1987-04-14
WAKO(TM) AUTOKIT LDH (K870401)Wako Chemicals USA, Inc.1987-03-06
LDH S.C.E. (K863068)J. D. Assoc.1986-12-10
LACTATE DEHYDROGENASE(LD) PROCEDURE (K863255)Data Medical Associates, Inc.1986-10-03
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 (K863477)Em Diagnostic Systems, Inc.1986-09-26
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 (K863545)Em Diagnostic Systems, Inc.1986-09-25
KING DIAGNOSTICS LDH TEST (K862306)King Diagnostics, Inc.1986-08-19
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (K862255)Sterling Diagnostics, Inc.1986-07-29
LDP REAGENT CARTRIDGE (NO. 88216) (K862027)Hi Chem, Inc.1986-06-13
LACTATE DEHYDROGENASE (LD) PROCEDURE (K861662)Data Medical Associates, Inc.1986-05-29
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE (K861419)Hi Chem, Inc.1986-04-28
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. (K860713)Catachem, Inc.1986-04-24
L D H-L (LACTIC DEHYDROGENASE) REAGENT (K860728)Trace Scientific , Ltd.1986-04-07
LDH-P (LACTIC DEHYDROGENASE) REAGENT (K860729)Trace Scientific , Ltd.1986-04-07
LDH (OPTIMIZED) REAGENT (K860029)Sigma Chemical Co.1986-02-06
LACTIC DEHYDROGENASE (VV) REAGENT SET (K855157)Technostics Intl.1986-01-21
LACTIC DEHYDROGENASE REAGENT SET (K855159)Technostics Intl.1986-01-14
ULTRAZYME PLUS & SYSTEMATE LDH (K854585)Em Diagnostic Systems, Inc.1985-12-05
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI (K852948)Amresco, Inc.1985-08-07
LD-L REAGENT (K851996)Alpkem Corp.1985-05-31
LD-P REAGENT (K851997)Alpkem Corp.1985-05-30
LDH REAGENT FOR DEMAND ANALYZER (K850378)Advanced Biomedical Methods, Inc.1985-03-01
SYSTEMATE LDH, 67210 (K843269)Em Diagnostic Systems, Inc.1984-09-13
LACTATE DEHYDROGENASE ASSAY KIT (K842507)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
LACTATE DENYDRO GENASE ASSAY KIT (K842244)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
SIGMS PROCED. 228 UV LACTATE DEHYDRO (K841917)Sigma Diagnostics, Inc.1984-06-14
TDX REA LDH (K841703)Abbott Laboratories1984-06-08
LDH-UV REAGENT SET (K841058)Medical Specialties, Inc.1984-05-01
KINETIC LDH, A< BLUE 610 METHOD (K840006)American Monitor Corp.1984-03-23
ASTRA SYSTEMS ENZYME MODULE LD-P (K832048)Beckman Instruments, Inc.1983-07-19
LACTIC DEHYDROGENASE REAGENT SET (K831415)Sterling Biochemical, Inc.1983-06-16
RAICHEM LDH-P REAGENT W/SEPARATE START- (K831419)Reagents Applications, Inc.1983-06-16
ASTRA SYSTEMS ENZYME MODULE (K831353)Beckman Instruments, Inc.1983-06-08
FLOW-PAC LDH REAGENT SET (K823721)Amresco, Inc.1983-01-09
OPTIMIZED UV-LDH REAGENT SET (K822492)Biorent Diagnostic, Inc.1982-09-17
RAICHEM LDH-L REAGENT (K822312)Reagents Applications, Inc.1982-08-27
LDH-UV REAGENT SET (K821201)Omega Medical Electronics1982-07-20
ULTRAZYME PLUS LDH (K821878)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS LDH, #64950,65038&65039 (K821466)Emd Chemicals, Inc.1982-06-01
LD-L TRIS SYSTEM PACK TEST (K820378)Boehringer Mannheim Corp.1982-03-08
LDH-L (K813496)Pointe Scientific, Inc.,1981-12-31
ULTRA ZYME PLUS LDH #64950, 65038 & 39 (K812590)Harleco1981-09-24
SPIN-CHEM LD-L REAGENT (K812472)Smithkline Diagnostics, Inc.1981-09-14
LDH-L LIQUID ENZYMATIC, KINETIC KIT (K810083)Bio-Analytics Laboratories, Inc.1981-01-28
SERALYZER LDH REAGENT STRIPS, CALIBR (K803019)Miles Laboratories, Inc.1980-12-22
BECKMAN LIQUID-STAT LD-L-UV ENZYME (K802572)Beckman Instruments, Inc.1980-11-12
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS (K800691)Diagnostic Solutions, Inc.1980-05-28
LDH (L-P) REAGENT (K800120)Gilford Diagnostics1980-02-13
COBAS-BLO REAGENTS (LACTATE DEHYDRO (K792658)Hoffmann-La Roche, Inc.1980-01-17
SPIN CHEM REAGENT, DETERMINATION OF LDH- (K791081)Smithkline Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF LD (LDH-P) (K791085)Smithkline Diagnostics, Inc.1979-07-17
LD-P REAGENT (LDH P-L REAGENT) (K790771)Gilford Diagnostics1979-05-15
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) (K790248)Boehringer Laboratories1979-04-04
SERUM, LACTIC DEHYDROGENASE (K790020)Fisher Scientific Co., LLC1979-02-08
LDH REAGENT SYSTEM (K781765)American Monitor Corp.1978-11-22
LDH (K781775)Gilford Diagnostics1978-11-22
NAD REDUCTION METHOD, LACTATE PYRIVATE (K781724)Medical Analysis Systems, Inc.1978-11-03
SINGLE VIAL LDH-L TRIS (K781538)Boehringer Mannheim Corp.1978-10-03
LDH (UV KINETIC) (K781128)Macomb Chemical Co.1978-08-10
SINGLE VIAL LACTATE (K780563)Boehringer Mannheim Corp.1978-04-18
ULTRAZYME PLUS LDH (K780101)Harleco1978-02-14
LACTATE DEHYDROGENASE (K780041)Beckman Instruments, Inc.1978-02-01
LACTATE DEHYDROGENASE (K771836)Gamma Enterprises, Inc.1977-11-22
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH (K772028)Harleco1977-11-15
Next →

Track CFJ automatically

Every clearance here is in the API, with alerts when new ones post.