Trace America, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Trace America, Inc. - FDA 510(k) Cleared Devices
22
Total
22
Cleared
0
Denied
Trace America, Inc. has 22 FDA 510(k) cleared chemistry devices. Based in Miami, US.
Historical record: 22 cleared submissions from 1988 to 2001.
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 America, Inc.
22 devices
Cleared
Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Chemistry
58d
Cleared
Mar 10, 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Chemistry
64d
Cleared
Feb 02, 1998
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
Chemistry
28d
Cleared
Jan 30, 1998
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
Chemistry
25d
Cleared
Jan 07, 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
Chemistry
105d
Cleared
Jan 02, 1998
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Chemistry
22d
Cleared
Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Chemistry
28d
Cleared
May 27, 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Chemistry
34d
Cleared
May 27, 1997
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Chemistry
34d
Cleared
Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
Chemistry
241d
Cleared
Dec 10, 1996
PORPHOBILINOGEN (PBG)
Chemistry
203d
Cleared
Aug 05, 1996
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
Chemistry
109d