Teco Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
55
Inspections
5
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K170118Scanostics UTI Check Application Test SystemSeptember 21, 2017
K161527Teco Creatinine Enzymatic Reagent KitJuly 21, 2017
K170200Carbon Dioxide Reagent SetJune 1, 2017
K160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEMJuly 22, 2016
K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEMMarch 7, 2016
K141289TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPSJuly 24, 2015
K131600URS-2GP (GLUCOSE PROTEIN) URINE STRIPSMay 29, 2014
K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTOctober 4, 2011
K100024TECO DIAGNOSTICS UTI DETECTION STRIPSFebruary 17, 2011
K101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10February 4, 2011
K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERMay 8, 2008
K072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440April 18, 2008
K063701TECO HOMOCYSTEINE ENZYMATIC ASSAYApril 11, 2007
K061419TECO MICROALBUMIN 2-1 COMBO STRIPSJanuary 26, 2007
K061065FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25July 14, 2006
K060364VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBEJune 15, 2006
K060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMMarch 27, 2006
K052724TECO ISE REAGENT SET FOR CX SYSTEMDecember 14, 2005
K051526URITEK-720+ URINE ANALYZERAugust 16, 2005
K051121DIRECT LDL CHOLESTEROL, MODEL L530-60HAugust 8, 2005