Trace Scientific, Ltd.
Clayton, Vic 3168, AU
Trace Scientific , Ltd. appears in FDA device records in Clayton, Vic 3168, AU. FDA records list 55 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 55
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Trace Scientific, Ltd. between 1986 and 1998. The busiest year on record is 1987, with 20. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 14 |
| 1987 | 20 |
| 1988 | 2 |
| 1989 | 5 |
| 1990 | 4 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | DBM | Substantially Equivalent | |
| K981123 | UREA | CDQ | Substantially Equivalent | |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | CHH | Substantially Equivalent | |
| K961114 | AST INCORPORATING DST | CIT | Substantially Equivalent | |
| K961123 | ALT INCORPORATING DST | CKA | Substantially Equivalent | |
| K952488 | TRACE COBAS MIRA RANGE | CIX | Substantially Equivalent | |
| K932713 | TRACE TRANSFERRIN REAGENT | DDQ | Substantially Equivalent | |
| K923322 | TRACE ALBUMIN-MR REAGENT | CIX | Substantially Equivalent | |
| K914731 | TRACE GAMMA GT-SS REAGENT | JQB | Substantially Equivalent | |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | CDT | Substantially Equivalent | |
| K904116 | IRON 5 X CONC REAGENT | JMO | Substantially Equivalent | |
| K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT | CHH | Substantially Equivalent | |
| K903896 | CALCIUM ARSENAZO III REAGENT | CIC | Substantially Equivalent | |
| K891468 | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | CIT | Substantially Equivalent | |
| K891470 | CK-NAC 2-VIAL REAGENT W/SUBSTRATE START | CGS | Substantially Equivalent | |
| K890996 | LD1 ISOENZYME REAGENT KIT | JGF | Substantially Equivalent | |
| K891469 | ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | CKA | Substantially Equivalent | |
| K890070 | TOTAL BILIRUBIN REAGENT, CONCENTRATED | CIG | Substantially Equivalent | |
| K881938 | BICARBONATE (CO2) REAGENT-2 VIAL | KHS | Substantially Equivalent | |
| K881244 | HDL CHOLESTEROL KIT | LBR | Substantially Equivalent | |
| K874055 | IRON REAGENT | JMO | Substantially Equivalent | |
| K870367 | CHLORIDE REAGENT - THIOCYANATE METHOD | CHJ | Substantially Equivalent | |
| K870362 | CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD | CIC | Substantially Equivalent | |
| K872484 | MODIFIED ENZYMATIC BUN REAGENT | CDQ | Substantially Equivalent | |
| K872483 | MODIFIED ALT (GPT) REAGENT | CKA | Substantially Equivalent | |
| K870372 | ALBUMIN REAGENT - BROMCRESOL GREEN METHOD | CIX | Substantially Equivalent | |
| K870371 | TOTAL PROTEIN REAGENT - BIURET METHOD | CEK | Substantially Equivalent | |
| K870370 | MAGNESIUM REAGENT - CALMAGITE METHOD | JGJ | Substantially Equivalent | |
| K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | CIA | Substantially Equivalent | |
| K870368 | PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION | CEO | Substantially Equivalent | |
| K870366 | CREATININE REAGENT - PICRIC ACID METHOD | CGX | Substantially Equivalent | |
| K870365 | DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD | CIG | Substantially Equivalent | |
| K870364 | TOTAL BILIRUBIN REAGENT - DMSO METHOD | CIG | Substantially Equivalent | |
| K871509 | RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) | CDT | Substantially Equivalent | |
| K871508 | RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL | CDT | Substantially Equivalent | |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | KHG | Substantially Equivalent | |
| K864360 | LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE | Substantially Equivalent | ||
| K864359 | CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) | CGS | Substantially Equivalent | |
| K864357 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT | CIT | Substantially Equivalent | |
| K864356 | AMYLASE REAGENT | CIJ | Substantially Equivalent | |
| K860733 | CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE | CGS | Substantially Equivalent | |
| K860716 | ENZYMATIC BUN REAGENT | CDQ | Substantially Equivalent | |
| K860715 | ALP (ALKALINE PHOSPHATASE) REAGENT | CJE | Substantially Equivalent | |
| K860726 | ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID | LFR | Substantially Equivalent | |
| K860732 | ENZYMATIC URIC ACID REAGENT | KNK | Substantially Equivalent | |
| K860717 | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) | CHH | Substantially Equivalent | |
| K860731 | TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) | JGY | Substantially Equivalent | |
| K860730 | ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) | CDT | Substantially Equivalent | |
| K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT | CFJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DDQAntigen, Antiserum, Control, Antithrombin Iii
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- JGYColorimetric Method, Triglycerides
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- LFRGlucose Dehydrogenase, Glucose
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CIAMethylthymol Blue, Calcium
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CIJSaccharogenic, Amylase
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- KHGWhole Blood Hemoglobin Determination
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain