Company ยท AU
Trace Scientific , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1998. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 4 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIA | Methylthymol Blue, Calcium | 1 |
| CIJ | Saccharogenic, Amylase | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 1998 | K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT Trace Scientific , Ltd. | DBM |
| Apr 24, 1998 | K981123 | UREA Trace Scientific , Ltd., AU | CDQ |
| Sep 27, 1996 | K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) Trace Scientific , Ltd. | CHH |
| May 23, 1996 | K961114 | AST INCORPORATING DST Trace Scientific , Ltd. | CIT |
| Apr 25, 1996 | K961123 | ALT INCORPORATING DST Trace Scientific , Ltd. | CKA |
| Oct 13, 1995 | K952488 | TRACE COBAS MIRA RANGE Trace Scientific , Ltd. | CIX |
| Sep 30, 1993 | K932713 | TRACE TRANSFERRIN REAGENT Trace Scientific , Ltd., AU | DDQ |
| Sep 11, 1992 | K923322 | TRACE ALBUMIN-MR REAGENT Trace Scientific , Ltd. | CIX |
| Nov 19, 1991 | K914731 | TRACE GAMMA GT-SS REAGENT Trace Scientific , Ltd., AU | JQB |
| Jul 17, 1991 | K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT Trace Scientific , Ltd., AU | CIG |
| Oct 1, 1990 | K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. Trace Scientific , Ltd., AU | CDT |
| Sep 27, 1990 | K904116 | IRON 5 X CONC REAGENT Trace Scientific , Ltd., AU | JMO |
| Sep 25, 1990 | K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT Trace Scientific , Ltd., AU | CHH |
| Sep 13, 1990 | K903896 | CALCIUM ARSENAZO III REAGENT Trace Scientific , Ltd., AU | CIC |
| May 22, 1989 | K891468 | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT Trace Scientific , Ltd., AU | CIT |
| May 9, 1989 | K891470 | CK-NAC 2-VIAL REAGENT W/SUBSTRATE START Trace Scientific , Ltd., AU | CGS |
| May 5, 1989 | K890996 | LD1 ISOENZYME REAGENT KIT Trace Scientific , Ltd., AU | JGF |
| Apr 4, 1989 | K891469 | ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT Trace Scientific , Ltd., AU | CKA |
| Mar 6, 1989 | K890070 | TOTAL BILIRUBIN REAGENT, CONCENTRATED Trace Scientific , Ltd., AU | CIG |
| Jun 15, 1988 | K881938 | BICARBONATE (CO2) REAGENT-2 VIAL Trace Scientific , Ltd., AU | KHS |
| Jun 10, 1988 | K881244 | HDL CHOLESTEROL KIT Trace Scientific , Ltd., AU | LBR |
| Oct 28, 1987 | K874055 | IRON REAGENT Trace Scientific , Ltd., AU | JMO |
| Aug 21, 1987 | K870367 | CHLORIDE REAGENT - THIOCYANATE METHOD Trace Scientific , Ltd., AU | CHJ |
| Aug 21, 1987 | K870362 | CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD Trace Scientific , Ltd., AU | CIC |
| Aug 19, 1987 | K872484 | MODIFIED ENZYMATIC BUN REAGENT Trace Scientific , Ltd. | CDQ |
| Aug 19, 1987 | K872483 | MODIFIED ALT (GPT) REAGENT Trace Scientific , Ltd. | CKA |
| Aug 19, 1987 | K870372 | ALBUMIN REAGENT - BROMCRESOL GREEN METHOD Trace Scientific , Ltd., AU | CIX |
| Aug 19, 1987 | K870371 | TOTAL PROTEIN REAGENT - BIURET METHOD Trace Scientific , Ltd., AU | CEK |
| Aug 19, 1987 | K870370 | MAGNESIUM REAGENT - CALMAGITE METHOD Trace Scientific , Ltd., AU | JGJ |
| Aug 19, 1987 | K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD Trace Scientific , Ltd., AU | CIA |
| Aug 19, 1987 | K870368 | PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION Trace Scientific , Ltd., AU | CEO |
| Aug 19, 1987 | K870366 | CREATININE REAGENT - PICRIC ACID METHOD Trace Scientific , Ltd., AU | CGX |
| Aug 19, 1987 | K870365 | DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD Trace Scientific , Ltd., AU | CIG |
| Aug 19, 1987 | K870364 | TOTAL BILIRUBIN REAGENT - DMSO METHOD Trace Scientific , Ltd., AU | CIG |
| May 8, 1987 | K871509 | RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) Trace Scientific , Ltd., AU | CDT |
| May 8, 1987 | K871508 | RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL Trace Scientific , Ltd., AU | CDT |
| Mar 16, 1987 | K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD Trace Scientific , Ltd., AU | KHG |
| Feb 6, 1987 | K864360 | LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE Trace Scientific , Ltd., AU | |
| Feb 6, 1987 | K864359 | CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) Trace Scientific , Ltd., AU | CGS |
| Feb 6, 1987 | K864357 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT Trace Scientific , Ltd., AU | CIT |
| Jan 21, 1987 | K864356 | AMYLASE REAGENT Trace Scientific , Ltd., AU | CIJ |
| Apr 24, 1986 | K860733 | CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE Trace Scientific , Ltd., AU | CGS |
| Apr 24, 1986 | K860716 | ENZYMATIC BUN REAGENT Trace Scientific , Ltd., AU | CDQ |
| Apr 24, 1986 | K860715 | ALP (ALKALINE PHOSPHATASE) REAGENT Trace Scientific , Ltd., AU | CJE |
| Apr 21, 1986 | K860726 | ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID Trace Scientific , Ltd., AU | LFR |
| Apr 16, 1986 | K860732 | ENZYMATIC URIC ACID REAGENT Trace Scientific , Ltd., AU | KNK |
| Apr 11, 1986 | K860717 | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) Trace Scientific , Ltd., AU | CHH |
| Apr 7, 1986 | K860731 | TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) Trace Scientific , Ltd., AU | JGY |
| Apr 7, 1986 | K860730 | ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) Trace Scientific , Ltd., AU | CDT |
| Apr 7, 1986 | K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT Trace Scientific , Ltd., AU | CFJ |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||