Trace Scientific , Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Trace Scientific , Ltd. - FDA 510(k) Cleared Devices
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.
FDA 510(k) Regulatory Record - Trace Scientific , Ltd.
55 devices
Cleared
Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
Immunology
93d
Cleared
Apr 24, 1998
UREA
Chemistry
28d
Cleared
Sep 27, 1996
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
Chemistry
65d
Cleared
May 23, 1996
AST INCORPORATING DST
Chemistry
64d
Cleared
Apr 25, 1996
ALT INCORPORATING DST
Chemistry
35d
Cleared
Oct 13, 1995
TRACE COBAS MIRA RANGE
Chemistry
136d
Cleared
Sep 30, 1993
TRACE TRANSFERRIN REAGENT
Hematology
118d
Cleared
Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
Hematology
66d
Cleared
Nov 19, 1991
TRACE GAMMA GT-SS REAGENT
Chemistry
29d
Cleared
Jul 17, 1991
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
Chemistry
82d
Cleared
Oct 01, 1990
TRIGLYCERIDES REAGENT GPO 5 X CONC.
Chemistry
39d
Cleared
Sep 27, 1990
IRON 5 X CONC REAGENT
Chemistry
21d
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