Medical Device Manufacturer · US , Miami , FL

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

22 submissions · 22 cleared · Since 1988

Total

Cleared

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.

Trace America, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Trace America, Inc.

22 devices

1-22 of 22

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

TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY

TRACE MICROPROTEIN REAGENT

K925794 · JGQ

Chemistry · 133d

Cleared Mar 11, 1992

TRACE MAGNESIUM - ARSENAZO REAGENT

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL

K880794 · KHS

Chemistry · 52d

Cleared Apr 18, 1988

RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.

K880795 · CJE

Chemistry · 52d

Cleared Apr 18, 1988

ALKALINE PHOSPHATASE REAGENT, DEA BUFF

K880796 · CJE

Chemistry · 52d

Cleared Apr 18, 1988

ACID PHOSPHATASE REAGENT

K880798 · CKB

Chemistry · 52d

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

FDA 510(k) Regulatory Record - Trace America, Inc.

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