Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trace Scientific , Ltd. — Predicate Candidate Screening
55 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
203 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Trace Scientific , Ltd. | 1998-09-17 | 93 | 0 |
| K981123 | UREA | Trace Scientific , Ltd. | 1998-04-24 | 28 | 0 |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | Trace Scientific , Ltd. | 1996-09-27 | 65 | 0 |
| K961114 | AST INCORPORATING DST | Trace Scientific , Ltd. | 1996-05-23 | 64 | 0 |
| K961123 | ALT INCORPORATING DST | Trace Scientific , Ltd. | 1996-04-25 | 35 | 0 |
| K952488 | TRACE COBAS MIRA RANGE | Trace Scientific , Ltd. | 1995-10-13 | 136 | 0 |
| K932713 | TRACE TRANSFERRIN REAGENT | Trace Scientific , Ltd. | 1993-09-30 | 118 | 0 |
| K923322 | TRACE ALBUMIN-MR REAGENT | Trace Scientific , Ltd. | 1992-09-11 | 66 | 0 |
| K914731 | TRACE GAMMA GT-SS REAGENT | Trace Scientific , Ltd. | 1991-11-19 | 29 | 0 |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | Trace Scientific , Ltd. | 1991-07-17 | 82 | 0 |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | Trace Scientific , Ltd. | 1990-10-01 | 39 | 0 |
| K904116 | IRON 5 X CONC REAGENT | Trace Scientific , Ltd. | 1990-09-27 | 21 | 0 |
| K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT | Trace Scientific , Ltd. | 1990-09-25 | 98 | 0 |
| K903896 | CALCIUM ARSENAZO III REAGENT | Trace Scientific , Ltd. | 1990-09-13 | 21 | 0 |
| K891468 | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | Trace Scientific , Ltd. | 1989-05-22 | 68 | 0 |
| K891470 | CK-NAC 2-VIAL REAGENT W/SUBSTRATE START | Trace Scientific , Ltd. | 1989-05-09 | 55 | 0 |
| K890996 | LD1 ISOENZYME REAGENT KIT | Trace Scientific , Ltd. | 1989-05-05 | 67 | 0 |
| K891469 | ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | Trace Scientific , Ltd. | 1989-04-04 | 20 | 0 |
| K890070 | TOTAL BILIRUBIN REAGENT, CONCENTRATED | Trace Scientific , Ltd. | 1989-03-06 | 56 | 0 |
| K881938 | BICARBONATE (CO2) REAGENT-2 VIAL | Trace Scientific , Ltd. | 1988-06-15 | 37 | 0 |
| K881244 | HDL CHOLESTEROL KIT | Trace Scientific , Ltd. | 1988-06-10 | 79 | 0 |
| K874055 | IRON REAGENT | Trace Scientific , Ltd. | 1987-10-28 | 23 | 0 |
| K870362 | CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD | Trace Scientific , Ltd. | 1987-08-21 | 205 | 0 |
| K870367 | CHLORIDE REAGENT - THIOCYANATE METHOD | Trace Scientific , Ltd. | 1987-08-21 | 205 | 0 |
| K872484 | MODIFIED ENZYMATIC BUN REAGENT | Trace Scientific , Ltd. | 1987-08-19 | 56 | 0 |
| K870372 | ALBUMIN REAGENT - BROMCRESOL GREEN METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K872483 | MODIFIED ALT (GPT) REAGENT | Trace Scientific , Ltd. | 1987-08-19 | 56 | 0 |
| K870368 | PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K870366 | CREATININE REAGENT - PICRIC ACID METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K870371 | TOTAL PROTEIN REAGENT - BIURET METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K870365 | DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K870370 | MAGNESIUM REAGENT - CALMAGITE METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K870364 | TOTAL BILIRUBIN REAGENT - DMSO METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K871508 | RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL | Trace Scientific , Ltd. | 1987-05-08 | 22 | 0 |
| K871509 | RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) | Trace Scientific , Ltd. | 1987-05-08 | 22 | 0 |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | Trace Scientific , Ltd. | 1987-03-16 | 47 | 0 |
| K864359 | CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) | Trace Scientific , Ltd. | 1987-02-06 | 95 | 0 |
| K864357 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1987-02-06 | 95 | 0 |
| K864360 | LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE | Trace Scientific , Ltd. | 1987-02-06 | 95 | 0 |
| K864356 | AMYLASE REAGENT | Trace Scientific , Ltd. | 1987-01-21 | 79 | 0 |
| K860716 | ENZYMATIC BUN REAGENT | Trace Scientific , Ltd. | 1986-04-24 | 57 | 0 |
| K860733 | CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE | Trace Scientific , Ltd. | 1986-04-24 | 57 | 0 |
| K860715 | ALP (ALKALINE PHOSPHATASE) REAGENT | Trace Scientific , Ltd. | 1986-04-24 | 57 | 0 |
| K860726 | ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID | Trace Scientific , Ltd. | 1986-04-21 | 54 | 0 |
| K860732 | ENZYMATIC URIC ACID REAGENT | Trace Scientific , Ltd. | 1986-04-16 | 49 | 0 |
| K860717 | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) | Trace Scientific , Ltd. | 1986-04-11 | 44 | 0 |
| K860727 | ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | 40 | 0 |
| K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | 40 | 0 |
| K860724 | ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) | Trace Scientific , Ltd. | 1986-04-07 | 40 | 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