FDA Product Code
FDA Product Code CFJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1440
510(k) Clearances — 111 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-10-02 | Traditional | PDF ↗ |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Alfa Wassermann, Inc. | 2009-09-09 | Traditional | PDF ↗ |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Abaxis, Inc. | 2005-07-08 | Traditional | PDF ↗ |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | Diagnostic Chemicals , Ltd. | 1998-01-22 | Traditional | PDF ↗ |
| K973589 | LIQUID LDH-L REAGENT SET | Pointe Scientific, Inc., | 1997-10-08 | Traditional | PDF ↗ |
| K970684 | LACTATE DEHYDROGENASE (LD) | Randox Laboratories, Ltd. | 1997-05-07 | Traditional | PDF ↗ |
| K971398 | LD-L REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-02 | Traditional | PDF ↗ |
| K964912 | LACTATE DEHYDROGENASE | Derma Media Lab., Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | Pointe Scientific, Inc., | 1996-06-03 | Traditional | PDF ↗ |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K946022 | HICHEM LDH/L REAGENT KIT | Hichem Diagnostics | 1995-02-23 | Traditional | PDF ↗ |
| K942964 | LACTATE DEHYDROGENASE QVET | Prisma Systems | 1994-12-29 | Traditional | PDF ↗ |
| K935175 | LACTATE DEHYDROGENASE (LD) | Em Diagnostic Systems, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Em Diagnostic Systems, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-11-16 | Traditional | PDF ↗ |
| K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-09-18 | Traditional | PDF ↗ |
| K921025 | SYNERMED LDHH-L REAGENT KIT | Synermed, Inc. | 1992-03-23 | Traditional | PDF ↗ |
| K915803 | DMA LD KINETIC PROCEDURE | Data Medical Associates, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K914262 | ABBOTT QUICKSTART LDH,#5A31 | Em Diagnostic Systems, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K910640 | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 | Em Diagnostic Systems, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Biotrol, USA, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K903773 | SYNERMED LDH REAGENT KIT | Synermed, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | American Research Products Co. | 1990-04-19 | Traditional | PDF ↗ |
| K900121 | ROCHE REAGENT FOR LDH | Roche Diagnostic Systems, Inc. | 1990-03-30 | Traditional | PDF ↗ |
| K897164 | COULTER LD (LDH-L) REAGENT | Coulter Electronics, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K896241 | COBAS READY LDH REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K894482 | LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 | Em Diagnostic Systems, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K884548 | LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 | Em Diagnostic Systems, Inc. | 1988-11-10 | Traditional | PDF ↗ |
| K883206 | LACTATE DEHYDROGENASE LDH | Electro-Nucleonics, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K881474 | VISION(R) LDH (LACTATE DEHYDROGENASE) | Abbott Laboratories | 1988-06-01 | Traditional | PDF ↗ |
| K880842 | LDH-L REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K875206 | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-02 | Traditional | PDF ↗ |
| K874848 | LACTATE DEHYDROGENASE LDH-L | Tech-Co, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K872030 | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) | Sclavo, Inc. | 1987-07-07 | Traditional | PDF ↗ |
| K872010 | MULTICHEM LDH-L REAGENT | Simmler, Inc. | 1987-06-11 | Traditional | PDF ↗ |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | Biochemical Trade, Inc. | 1987-06-03 | Traditional | PDF ↗ |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Miles Laboratories, Inc. | 1987-04-14 | Traditional | PDF ↗ |
| K870401 | WAKO(TM) AUTOKIT LDH | Wako Chemicals USA, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K863068 | LDH S.C.E. | J. D. Assoc. | 1986-12-10 | Traditional | PDF ↗ |
| K863255 | LACTATE DEHYDROGENASE(LD) PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K863477 | EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 | Em Diagnostic Systems, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863545 | EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 | Em Diagnostic Systems, Inc. | 1986-09-25 | Traditional | PDF ↗ |
| K862306 | KING DIAGNOSTICS LDH TEST | King Diagnostics, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | Sterling Diagnostics, Inc. | 1986-07-29 | Traditional | PDF ↗ |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Hi Chem, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K861662 | LACTATE DEHYDROGENASE (LD) PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE | Hi Chem, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. | Catachem, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860029 | LDH (OPTIMIZED) REAGENT | Sigma Chemical Co. | 1986-02-06 | Traditional | PDF ↗ |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | Technostics Intl. | 1986-01-21 | Traditional | PDF ↗ |
| K855159 | LACTIC DEHYDROGENASE REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K854585 | ULTRAZYME PLUS & SYSTEMATE LDH | Em Diagnostic Systems, Inc. | 1985-12-05 | Traditional | PDF ↗ |
| K852948 | AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI | Amresco, Inc. | 1985-08-07 | Traditional | PDF ↗ |
| K851996 | LD-L REAGENT | Alpkem Corp. | 1985-05-31 | Traditional | PDF ↗ |
| K851997 | LD-P REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K843269 | SYSTEMATE LDH, 67210 | Em Diagnostic Systems, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K842507 | LACTATE DEHYDROGENASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-20 | Traditional | PDF ↗ |
| K842244 | LACTATE DENYDRO GENASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-18 | Traditional | PDF ↗ |
| K841917 | SIGMS PROCED. 228 UV LACTATE DEHYDRO | Sigma Diagnostics, Inc. | 1984-06-14 | Traditional | PDF ↗ |
| K841703 | TDX REA LDH | Abbott Laboratories | 1984-06-08 | Traditional | PDF ↗ |
| K841058 | LDH-UV REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840006 | KINETIC LDH, A< BLUE 610 METHOD | American Monitor Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K832048 | ASTRA SYSTEMS ENZYME MODULE LD-P | Beckman Instruments, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- | Reagents Applications, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | Sterling Biochemical, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K831353 | ASTRA SYSTEMS ENZYME MODULE | Beckman Instruments, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K823721 | FLOW-PAC LDH REAGENT SET | Amresco, Inc. | 1983-01-09 | Traditional | PDF ↗ |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | Biorent Diagnostic, Inc. | 1982-09-17 | Traditional | PDF ↗ |
| K822312 | RAICHEM LDH-L REAGENT | Reagents Applications, Inc. | 1982-08-27 | Traditional | PDF ↗ |
| K821201 | LDH-UV REAGENT SET | Omega Medical Electronics | 1982-07-20 | Traditional | PDF ↗ |
| K821878 | ULTRAZYME PLUS LDH | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K821466 | ULTRAZYME PLUS LDH, #64950,65038&65039 | Emd Chemicals, Inc. | 1982-06-01 | Traditional | PDF ↗ |
| K820378 | LD-L TRIS SYSTEM PACK TEST | Boehringer Mannheim Corp. | 1982-03-08 | Traditional | PDF ↗ |
| K813496 | LDH-L | Pointe Scientific, Inc., | 1981-12-31 | Traditional | PDF ↗ |
| K812590 | ULTRA ZYME PLUS LDH #64950, 65038 & 39 | Harleco | 1981-09-24 | Traditional | PDF ↗ |
| K812472 | SPIN-CHEM LD-L REAGENT | Smithkline Diagnostics, Inc. | 1981-09-14 | Traditional | PDF ↗ |
| K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT | Bio-Analytics Laboratories, Inc. | 1981-01-28 | Traditional | PDF ↗ |
| K803019 | SERALYZER LDH REAGENT STRIPS, CALIBR | Miles Laboratories, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802572 | BECKMAN LIQUID-STAT LD-L-UV ENZYME | Beckman Instruments, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800120 | LDH (L-P) REAGENT | Gilford Diagnostics | 1980-02-13 | Traditional | PDF ↗ |
| K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO | Hoffmann-La Roche, Inc. | 1980-01-17 | Traditional | PDF ↗ |
| K791085 | PLUS CHEM, DETERMINATION OF LD (LDH-P) | Smithkline Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K791081 | SPIN CHEM REAGENT, DETERMINATION OF LDH- | Smithkline Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K790771 | LD-P REAGENT (LDH P-L REAGENT) | Gilford Diagnostics | 1979-05-15 | Traditional | PDF ↗ |
| K790248 | NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) | Boehringer Laboratories | 1979-04-04 | Traditional | PDF ↗ |
| K790020 | SERUM, LACTIC DEHYDROGENASE | Fisher Scientific Co., LLC | 1979-02-08 | Traditional | PDF ↗ |
| K781775 | LDH | Gilford Diagnostics | 1978-11-22 | Traditional | PDF ↗ |
| K781765 | LDH REAGENT SYSTEM | American Monitor Corp. | 1978-11-22 | Traditional | PDF ↗ |
| K781724 | NAD REDUCTION METHOD, LACTATE PYRIVATE | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K781538 | SINGLE VIAL LDH-L TRIS | Boehringer Mannheim Corp. | 1978-10-03 | Traditional | PDF ↗ |
| K781128 | LDH (UV KINETIC) | Macomb Chemical Co. | 1978-08-10 | Traditional | PDF ↗ |
| K780563 | SINGLE VIAL LACTATE | Boehringer Mannheim Corp. | 1978-04-18 | Traditional | PDF ↗ |
| K780101 | ULTRAZYME PLUS LDH | Harleco | 1978-02-14 | Traditional | PDF ↗ |
| K780041 | LACTATE DEHYDROGENASE | Beckman Instruments, Inc. | 1978-02-01 | Traditional | PDF ↗ |
| K771836 | LACTATE DEHYDROGENASE | Gamma Enterprises, Inc. | 1977-11-22 | Traditional | PDF ↗ |
| K772028 | GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH | Harleco | 1977-11-15 | Traditional | PDF ↗ |
Product code CFJ · Class II · Clinical Chemistry. Data: openFDA.