Trace America, Inc. - FDA 510(k) Cleared Devices

Cleared Jan 17, 2001

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901

K003583 · NDW

Chemistry · 58d

Cleared Mar 10, 1998

GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K980026 · CFR

Chemistry · 64d

Cleared Feb 02, 1998

ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...

K980028 · CKA

Chemistry · 28d

Cleared Jan 30, 1998

AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...

K980030 · CIT

Chemistry · 25d

Cleared Jan 07, 1998

TRACE REAGENT LINE FOR THE COBAS MIRA

K973869 · CKA

Chemistry · 105d

Cleared Jan 02, 1998

AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

K974620 · JIF

Chemistry · 22d

Cleared Jul 17, 1997

AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K972297 · JFJ

Chemistry · 28d

Cleared May 27, 1997

UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

K971477 · CDQ

Chemistry · 34d

Cleared May 27, 1997

URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K971485 · CDO

Chemistry · 34d

Cleared Mar 13, 1997

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN

K962723 · LBR

Chemistry · 241d

Cleared Dec 10, 1996

PORPHOBILINOGEN (PBG)

K961984 · JNF

Chemistry · 203d

Cleared Aug 05, 1996

TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY

K961477 · CDT

Chemistry · 109d