Medical Device Manufacturer · AU , Clayton, Vic 3168

Trace Scientific , Ltd.

55 submissions · 55 cleared · Since 1986
55
Total
55
Cleared
0
Denied

Trace Scientific , Ltd. has 55 FDA 510(k) cleared chemistry devices. Based in Clayton, Vic 3168, AU.

Historical record: 55 cleared submissions from 1986 to 1998.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

55 devices
1–12 of 55
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control · Immunology
Sep 1998 93d
UREA
K981123 · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen · Chemistry
Apr 1998 28d
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · CHH Enzymatic Esterase--oxidase, Cholesterol · Chemistry
Sep 1996 65d
AST INCORPORATING DST
K961114 · CIT Nadh Oxidation/nad Reduction, Ast/sgot · Chemistry
May 1996 64d
ALT INCORPORATING DST
K961123 · CKA Nadh Oxidation/nad Reduction, Alt/sgpt · Chemistry
Apr 1996 35d
TRACE COBAS MIRA RANGE
K952488 · CIX Bromcresol Green Dye-binding, Albumin · Chemistry
Oct 1995 136d
TRACE TRANSFERRIN REAGENT
K932713 · DDQ Antigen, Antiserum, Control, Antithrombin Iii · Hematology
Sep 1993 118d
TRACE ALBUMIN-MR REAGENT
K923322 · CIX Bromcresol Green Dye-binding, Albumin · Hematology
Sep 1992 66d
TRACE GAMMA GT-SS REAGENT
K914731 · JQB Kinetic Method, Gamma-glutamyl Transpeptidase · Chemistry
Nov 1991 29d
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K911866 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jul 1991 82d
TRIGLYCERIDES REAGENT GPO 5 X CONC.
K903897 · CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · Chemistry
Oct 1990 39d
IRON 5 X CONC REAGENT
K904116 · JMO Ferrozine (colorimetric) Iron Binding Capacity · Chemistry
Sep 1990 21d

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