Panels › Clinical Chemistry › Product code CFJ · Class 2
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Regulation 862.1440
0510(k)s in 12 months (111 all time)
0recalls in 12 months (8 all time)
4recalls that name a 510(k)
Top companies in CFJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2013 | K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CFJ |
| Sep 9, 2009 | K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 Alfa Wassermann, Inc. | CFJ |
| Jul 8, 2005 | K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM Abaxis, Inc. | CFJ |
| Jan 22, 1998 | K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 Diagnostic Chemicals , Ltd., CA | CFJ |
| Oct 8, 1997 | K973589 | LIQUID LDH-L REAGENT SET Pointe Scientific, Inc., | CFJ |
| May 7, 1997 | K970684 | LACTATE DEHYDROGENASE (LD) Randox Laboratories, Ltd., IE | CFJ |
| May 2, 1997 | K971398 | LD-L REAGENT Carolina Liquid Chemistries Corp. | CFJ |
| Jan 9, 1997 | K964912 | LACTATE DEHYDROGENASE Derma Media Lab., Inc. | CFJ |
| Jun 3, 1996 | K961431 | LACTATE DEHYDROGENASE REAGENT SET Pointe Scientific, Inc., | CFJ |
| Aug 7, 1995 | K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CFJ |
| Feb 23, 1995 | K946022 | HICHEM LDH/L REAGENT KIT Hichem Diagnostics | CFJ |
| Dec 29, 1994 | K942964 | LACTATE DEHYDROGENASE QVET Prisma Systems | CFJ |
| Dec 16, 1993 | K935175 | LACTATE DEHYDROGENASE (LD) Em Diagnostic Systems, Inc. | CFJ |
| Feb 5, 1993 | K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 Em Diagnostic Systems, Inc. | CFJ |
| Nov 16, 1992 | K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT Olympus Corp. | CFJ |
| Sep 18, 1992 | K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT Olympus Corp. | CFJ |
| Mar 23, 1992 | K921025 | SYNERMED LDHH-L REAGENT KIT Synermed, Inc., CA | CFJ |
| Mar 18, 1992 | K915803 | DMA LD KINETIC PROCEDURE Data Medical Associates, Inc. | CFJ |
| Oct 11, 1991 | K914262 | ABBOTT QUICKSTART LDH,#5A31 Em Diagnostic Systems, Inc. | CFJ |
| Apr 12, 1991 | K910640 | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 Em Diagnostic Systems, Inc. | CFJ |
| Mar 11, 1991 | K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) Biotrol, USA, Inc. | CFJ |
| Oct 12, 1990 | K903773 | SYNERMED LDH REAGENT KIT Synermed, Inc., CA | CFJ |
| Apr 19, 1990 | K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 American Research Products Co. | CFJ |
| Mar 30, 1990 | K900121 | ROCHE REAGENT FOR LDH Roche Diagnostic Systems, Inc. | CFJ |
| Mar 9, 1990 | K897164 | COULTER LD (LDH-L) REAGENT Coulter Electronics, Inc. | CFJ |
| Feb 16, 1990 | K896241 | COBAS READY LDH REAGENT Roche Diagnostic Systems, Inc. | CFJ |
| Sep 7, 1989 | K894482 | LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 Em Diagnostic Systems, Inc. | CFJ |
| Nov 10, 1988 | K884548 | LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 Em Diagnostic Systems, Inc. | CFJ |
| Sep 9, 1988 | K883206 | LACTATE DEHYDROGENASE LDH Electro-Nucleonics, Inc. | CFJ |
| Jun 1, 1988 | K881474 | VISION(R) LDH (LACTATE DEHYDROGENASE) Abbott Laboratories | CFJ |
| Apr 5, 1988 | K880842 | LDH-L REAGENT SET Tech-Neal Scientific, Inc. | CFJ |
| Feb 2, 1988 | K875206 | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 Diagnostic Chemicals, Ltd. (Usa) | CFJ |
| Dec 18, 1987 | K874848 | LACTATE DEHYDROGENASE LDH-L Tech-Co, Inc. | CFJ |
| Jul 7, 1987 | K872030 | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) Sclavo, Inc. | CFJ |
| Jun 11, 1987 | K872010 | MULTICHEM LDH-L REAGENT Simmler, Inc. | CFJ |
| Jun 3, 1987 | K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET Biochemical Trade, Inc. | CFJ |
| Apr 14, 1987 | K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS Miles Laboratories, Inc. | CFJ |
| Mar 6, 1987 | K870401 | WAKO(TM) AUTOKIT LDH Wako Chemicals USA, Inc. | CFJ |
| Dec 10, 1986 | K863068 | LDH S.C.E. J. D. Assoc. | CFJ |
| Oct 3, 1986 | K863255 | LACTATE DEHYDROGENASE(LD) PROCEDURE Data Medical Associates, Inc. | CFJ |
| Sep 26, 1986 | K863477 | EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 Em Diagnostic Systems, Inc. | CFJ |
| Sep 25, 1986 | K863545 | EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 Em Diagnostic Systems, Inc. | CFJ |
| Aug 19, 1986 | K862306 | KING DIAGNOSTICS LDH TEST King Diagnostics, Inc. | CFJ |
| Jul 29, 1986 | K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) Sterling Diagnostics, Inc. | CFJ |
| Jun 13, 1986 | K862027 | LDP REAGENT CARTRIDGE (NO. 88216) Hi Chem, Inc. | CFJ |
| May 29, 1986 | K861662 | LACTATE DEHYDROGENASE (LD) PROCEDURE Data Medical Associates, Inc. | CFJ |
| Apr 28, 1986 | K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE Hi Chem, Inc. | CFJ |
| Apr 24, 1986 | K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. Catachem, Inc. | CFJ |
| Apr 7, 1986 | K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT Trace Scientific , Ltd., AU | CFJ |
| Apr 7, 1986 | K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT Trace Scientific , Ltd., AU | CFJ |
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