Product code CFJ
- Device name
- Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1440
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Alfa Wassermann, Inc. | 2009-09-09 |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Abaxis, Inc. | 2005-07-08 |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | Diagnostic Chemicals , Ltd. | 1998-01-22 |
| K973589 | LIQUID LDH-L REAGENT SET | Pointe Scientific, Inc., | 1997-10-08 |
| K970684 | LACTATE DEHYDROGENASE (LD) | Randox Laboratories, Ltd. | 1997-05-07 |
| K971398 | LD-L REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-02 |
| K964912 | LACTATE DEHYDROGENASE | Derma Media Lab., Inc. | 1997-01-09 |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | Pointe Scientific, Inc., | 1996-06-03 |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
| K946022 | HICHEM LDH/L REAGENT KIT | Hichem Diagnostics | 1995-02-23 |
| K942964 | LACTATE DEHYDROGENASE QVET | Prisma Systems | 1994-12-29 |
| K935175 | LACTATE DEHYDROGENASE (LD) | Em Diagnostic Systems, Inc. | 1993-12-16 |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Em Diagnostic Systems, Inc. | 1993-02-05 |
| K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-11-16 |
| K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-09-18 |
| K921025 | SYNERMED LDHH-L REAGENT KIT | Synermed, Inc. | 1992-03-23 |
| K915803 | DMA LD KINETIC PROCEDURE | Data Medical Associates, Inc. | 1992-03-18 |
| K914262 | ABBOTT QUICKSTART LDH,#5A31 | Em Diagnostic Systems, Inc. | 1991-10-11 |
| K910640 | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 | Em Diagnostic Systems, Inc. | 1991-04-12 |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Biotrol, USA, Inc. | 1991-03-11 |
| K903773 | SYNERMED LDH REAGENT KIT | Synermed, Inc. | 1990-10-12 |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | American Research Products Co. | 1990-04-19 |
| K900121 | ROCHE REAGENT FOR LDH | Roche Diagnostic Systems, Inc. | 1990-03-30 |
| K897164 | COULTER LD (LDH-L) REAGENT | Coulter Electronics, Inc. | 1990-03-09 |
| K896241 | COBAS READY LDH REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| K894482 | LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 | Em Diagnostic Systems, Inc. | 1989-09-07 |
| K884548 | LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 | Em Diagnostic Systems, Inc. | 1988-11-10 |
| K883206 | LACTATE DEHYDROGENASE LDH | Electro-Nucleonics, Inc. | 1988-09-09 |
| K881474 | VISION(R) LDH (LACTATE DEHYDROGENASE) | Abbott Laboratories | 1988-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740155339 | Alinity | ABBOTT IRELAND | 2025-12-19 |
| 00380740195236 | ARCHITECT | ABBOTT IRELAND | 2025-12-19 |
| 00380740195243 | ARCHITECT | ABBOTT IRELAND | 2025-12-19 |
| 00380740155322 | Alinity | ABBOTT IRELAND | 2025-12-19 |
| 00850053916137 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-12 |
| 10673486002065 | Teco Diagnostics LDH-L Reagent Set | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486002072 | Teco Diagnostics LDH-L Reagent Set | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486002058 | Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486002041 | Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486002034 | Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486002027 | Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | TECO DIAGNOSTICS | 2023-11-13 |
| 06971674863304 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863380 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863373 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863366 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863359 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863342 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863335 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863328 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863311 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863298 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863281 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863274 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863267 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 04015630916276 | Lactate Dehydrogenase acc to IFCC ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916337 | Lactate dehydrogenase liquid acc to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630922222 | Lactate dehydrogenase liquid acc to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630922246 | Lactate dehydrogenase liquid acc to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630925056 | Lactate Dehydrogenase acc to IFCC ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 03610230005576 | ABX PENTRA LDH IFCC CP | HORIBA ABX SAS | 2016-08-23 |