Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDT — Predicate Candidate Screening
151 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
108 days90th percentile
151clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150819 | Triglycerides | Randox Laboratories Limited | 2015-08-06 | 132 | 0 |
| K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | Siemens Healthcare Diagnostics, Inc. | 2013-11-22 | 56 | 1 |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 | 109 | 1 |
| K113830 | VANTERA CLINICAL ANALYZER | Liposcience | 2012-08-30 | 247 | 0 |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL | Seppim S.A.S. | 2011-05-19 | 223 | 0 |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Olympus America, Inc. | 2007-03-23 | 91 | 0 |
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAM | Dade Behring, Inc. | 2005-01-18 | 26 | 2 |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Clinical Data, Inc. | 2004-03-10 | 77 | 0 |
| K020488 | CARESIDE TRGLYCERIDE | Careside, Inc. | 2002-04-15 | 61 | 0 |
| K010871 | TGL FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-07-09 | 108 | 0 |
| K993466 | WAKO L-TYPE TRIGLYCERIDE TEST | Wako Chemicals USA, Inc. | 1999-11-09 | 27 | 0 |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | Carolina Liquid Chemistries Corp. | 1997-06-20 | 71 | 0 |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | Data Medical Associates, Inc. | 1997-05-29 | 63 | 0 |
| K964346 | PARAMAX TRIGLYCERID REAGENT | Dade Intl., Inc. | 1997-03-28 | 148 | 0 |
| K963424 | OLYMPUS LIPASE REAGENT | Olympus America, Inc. | 1997-01-14 | 137 | 1 |
| K961281 | TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 | Diagnostic Chemicals , Ltd. | 1996-08-16 | 135 | 0 |
| K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLO | Trace America, Inc. | 1996-08-05 | 109 | 0 |
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | Horizon Diagnostics, Inc. | 1996-06-13 | 1046 | 0 |
| K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISAT | Trace America, Inc. | 1996-04-05 | 226 | 0 |
| K960088 | TRUE TRIGLYCERIDE | Diagnostic Chemicals , Ltd. | 1996-04-01 | 81 | 0 |
| K952741 | TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-17 | 62 | 0 |
| K942998 | TRIGLYCERODES QVET | Prisma Systems | 1994-11-22 | 152 | 0 |
| K931891 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-08-25 | 132 | 0 |
| K923508 | TRIGLYCERIDES GPO-PAP | Randox Laboratories, Ltd. | 1993-07-28 | 378 | 0 |
| K924710 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-01-26 | 130 | 0 |
| K924573 | SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST | Em Diagnostic Systems, Inc. | 1992-11-06 | 57 | 0 |
| K924694 | LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC | Olympus Corp. | 1992-10-28 | 42 | 0 |
| K922964 | KING DIAGNOSTIC TRIGLYCERIDES REAGENT | King Diagnostics, Inc. | 1992-08-18 | 60 | 0 |
| K922229 | OLYMPUS TRIGLYCERIDE REAGENT | Olympus Corp. | 1992-07-02 | 51 | 0 |
| K915084 | BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT | Beckman Instruments, Inc. | 1992-01-28 | 77 | 0 |
| K915732 | ABBOTT QUICKSTART TIGLYCERIDES REAGENT | Em Diagnostic Systems, Inc. | 1992-01-15 | 26 | 0 |
| K914018 | ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 | Em Diagnostic Systems, Inc. | 1991-11-22 | 74 | 0 |
| K914609 | TRIGLYCERIDES REAGENT SET | Sterling Diagnostics, Inc. | 1991-11-07 | 21 | 0 |
| K910638 | SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 | Em Diagnostic Systems, Inc. | 1991-03-11 | 26 | 0 |
| K905601 | ECLIPSE ICA TRIGLYCERIDES | Biotope, Inc. | 1991-01-17 | 35 | 0 |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | Trace Scientific , Ltd. | 1990-10-01 | 39 | 0 |
| K903016 | SYNERMED TRIGLYCERIDES REAGENT KIT | Synermed, Inc. | 1990-07-27 | 17 | 0 |
| K897159 | COULTER TRIGLYCERIDES GPO REAGENT | Coulter Electronics, Inc. | 1990-03-09 | 71 | 0 |
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | Photec Diagnostics, Inc. | 1990-02-23 | 57 | 0 |
| K896231 | COBAS READY TRIGLYCERIDE REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | 109 | 0 |
| K895952 | TRIGLYCERIDES TEST KIT | Elite Technology, Inc. | 1990-01-11 | 92 | 0 |
| K894310 | AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) | American Research Products Co. | 1989-09-28 | 76 | 0 |
| K893917 | EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 | Em Diagnostic Systems, Inc. | 1989-08-28 | 90 | 0 |
| K893973 | ROCHE REAGENT FOR TRIGLYCERIDES | Roche Diagnostic Systems, Inc. | 1989-08-11 | 70 | 0 |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Alpkem Corp. | 1989-03-09 | 45 | 0 |
| K885266 | OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 | Em Diagnostic Systems, Inc. | 1989-02-07 | 47 | 0 |
| K883405 | TRIGLYCERIDES REAGENT (PRODUCT #88218) | Hichem Diagnostics | 1988-09-13 | 33 | 0 |
| K881702 | BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. | Biotrol, USA, Inc. | 1988-05-27 | 38 | 0 |
| K880238 | TRIGLYCERIDE | Tech-Neal Scientific, Inc. | 1988-03-15 | 55 | 0 |
| K880628 | TRIGLYCERIDES (GPO-TRINDER) | Tech-Co, Inc. | 1988-03-15 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda