Product code CDT
- Device name
- Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1705
- 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 |
|---|---|---|---|
| K150819 | Triglycerides | Randox Laboratories Limited | 2015-08-06 |
| K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | Siemens Healthcare Diagnostics, Inc. | 2013-11-22 |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 |
| K113830 | VANTERA CLINICAL ANALYZER | Liposcience | 2012-08-30 |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | Seppim S.A.S. | 2011-05-19 |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Olympus America, Inc. | 2007-03-23 |
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE | Dade Behring, Inc. | 2005-01-18 |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Clinical Data, Inc. | 2004-03-10 |
| K020488 | CARESIDE TRGLYCERIDE | Careside, Inc. | 2002-04-15 |
| K010871 | TGL FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-07-09 |
| K993466 | WAKO L-TYPE TRIGLYCERIDE TEST | Wako Chemicals USA, Inc. | 1999-11-09 |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | Carolina Liquid Chemistries Corp. | 1997-06-20 |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | Data Medical Associates, Inc. | 1997-05-29 |
| K964346 | PARAMAX TRIGLYCERID REAGENT | Dade Intl., Inc. | 1997-03-28 |
| K963424 | OLYMPUS LIPASE REAGENT | Olympus America, Inc. | 1997-01-14 |
| K961281 | TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 | Diagnostic Chemicals , Ltd. | 1996-08-16 |
| K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY | Trace America, Inc. | 1996-08-05 |
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | Horizon Diagnostics, Inc. | 1996-06-13 |
| K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY | Trace America, Inc. | 1996-04-05 |
| K960088 | TRUE TRIGLYCERIDE | Diagnostic Chemicals , Ltd. | 1996-04-01 |
| K952741 | TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-17 |
| K942998 | TRIGLYCERODES QVET | Prisma Systems | 1994-11-22 |
| K931891 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-08-25 |
| K923508 | TRIGLYCERIDES GPO-PAP | Randox Laboratories, Ltd. | 1993-07-28 |
| K924710 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-01-26 |
| K924573 | SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST | Em Diagnostic Systems, Inc. | 1992-11-06 |
| K924694 | LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC | Olympus Corp. | 1992-10-28 |
| K922964 | KING DIAGNOSTIC TRIGLYCERIDES REAGENT | King Diagnostics, Inc. | 1992-08-18 |
| K922229 | OLYMPUS TRIGLYCERIDE REAGENT | Olympus Corp. | 1992-07-02 |
| K915084 | BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT | Beckman Instruments, Inc. | 1992-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850053916151 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-12 |
| 10673486002256 | Teco Diagnostics Triglyceride - GPO Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-30 |
| 10673486002270 | Teco Diagnostics Triglyceride - GPO Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-28 |
| 10673486002287 | Teco Diagnostics Triglyceride - GPO Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-28 |
| 10673486002294 | Teco Diagnostics Triglyceride Reagent Kit TC-Matrix | TECO DIAGNOSTICS | 2023-11-28 |
| 10673486002225 | Teco Diagnostics Triglyceride -GPO Reagent Set | TECO DIAGNOSTICS | 2023-11-14 |
| 10673486002232 | Teco Diagnostics Triglyceride -GPO Reagent Set | TECO DIAGNOSTICS | 2023-11-14 |
| 06971674860372 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860365 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860358 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860341 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860334 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860327 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860310 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860303 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860280 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860266 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860228 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860389 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674868088 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-11 |
| 06971674860204 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860211 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860235 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860242 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 00630414610955 | Atellica CH Trig_2 | Siemens Healthcare Diagnostics Inc. | 2022-07-08 |
| B3959930030 | NMR Reference Standard | Labcorp of America | 2017-04-18 |
| B3959920030 | NMR Diluent 1 | Labcorp of America | 2017-04-18 |
| B3959910030 | NMR WASH Solution | Labcorp of America | 2016-11-11 |
| B3959900300 | Vantera Clinical Analyzer | Labcorp of America | 2016-11-11 |
| 00381931789012 | PTS Panels® Triglycerides Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-22 |