FDA.reportPublic FDA data

510(k) K012518

Device
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
Applicant
Thermo Dma, Inc.
510(k) number
K012518
Product code
CJE
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-09
Date received
2001-08-06
Regulation
862.1050
Classification name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS DOLLAR
Address
845 Ave. G E. Arlington TX US 76011 76011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx2006-07-21
K033185COBAS INTEGRA ALP IFCC GEN.2Roche Diagnostics Corp.2003-10-14