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Teco Diagnostics

FDA 510(k) & PMA Approved Devices — 49 products

Total Devices49
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K170118 Scanostics UTI Check Application Test SystemJMT2017-09-21 View
510(k) K111206 TECO DIAGNOSTICS SALIVA ALCOHOL TESTDIC2011-10-04 View
510(k) K100024 TECO DIAGNOSTICS UTI DETECTION STRIPSJMT2011-02-17 View
510(k) K101673 URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10JIL2011-02-04 View
510(k) K073370 TC MATRIX CLINICAL CHEMISTRY ANALYZERJJE2008-05-08 View
510(k) K072548 CREATINE KINASE LIQUID REAGENT, MODEL C519-440CGS2008-04-18 View
510(k) K063701 TECO HOMOCYSTEINE ENZYMATIC ASSAYLPS2007-04-11 View
510(k) K061419 TECO MICROALBUMIN 2-1 COMBO STRIPSJIR2007-01-26 View
510(k) K061065 FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25KHE2006-07-14 View
510(k) K060364 VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBEJKA2006-06-15 View
510(k) K060120 TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMCDQ2006-03-27 View
510(k) K052724 TECO ISE REAGENT SET FOR CX SYSTEMJGS2005-12-14 View
510(k) K051526 URITEK-720+ URINE ANALYZERKQO2005-08-16 View
510(k) K051200 HEMOGLOBIN A1C REAGENT SETLCP2005-08-08 View
510(k) K051121 DIRECT LDL CHOLESTEROL, MODEL L530-60HMRR2005-08-08 View
510(k) K050823 DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORLBR2005-07-26 View
510(k) K042421 URITEK 151 URINE ANALYZER, MODEL TC-151KQO2005-05-09 View
510(k) K040920 AMYLASE LIQUID REAGENT, MODEL A532-200JFJ2004-05-10 View
510(k) K023297 URS-1B (BLOOD TEST)JIO2003-03-06 View
510(k) K020175 URS-IG (GLUCOSE TEST)JIL2002-03-21 View
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