FDA 510(k) Applications Submitted by Teco Diagnostics

FDA 510(k) Number Submission Date Device Name Applicant
K970124 01/14/1997 LIPASE REAGENT SET (COLIPASE METHOD) TECO DIAGNOSTICS
K970120 01/14/1997 BILE ACIDS REAGENT SET TECO DIAGNOSTICS
K970250 01/22/1997 CLINISTRIP TECO DIAGNOSTICS
K970548 02/12/1997 ONE STEP MARIJUANA CARD TEST TECO DIAGNOSTICS
K970579 02/14/1997 ONE STEP MORPHINE CARD TEST TECO DIAGNOSTICS
K964461 11/07/1996 ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST TECO DIAGNOSTICS
K964462 11/07/1996 ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST TECO DIAGNOSTICS
K964536 11/12/1996 ONE-STEP DIPSTICK PREGNANCY TEST TECO DIAGNOSTICS
K141289 05/19/2014 TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS TECO DIAGNOSTICS
K000067 01/10/2000 ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H TECO DIAGNOSTICS
K000102 01/13/2000 GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 TECO DIAGNOSTICS
K010239 01/25/2001 COCAINE DIPSTICK TEST, MODEL D747-A TECO DIAGNOSTICS
K003987 12/26/2000 URS-1K (KETONE TESST) TECO DIAGNOSTICS
K111206 04/29/2011 TECO DIAGNOSTICS SALIVA ALCOHOL TEST TECO DIAGNOSTICS
K060120 01/17/2006 TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM TECO DIAGNOSTICS
K060364 02/13/2006 VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE TECO DIAGNOSTICS
K050823 03/31/2005 DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR TECO DIAGNOSTICS
K040920 04/08/2004 AMYLASE LIQUID REAGENT, MODEL A532-200 TECO DIAGNOSTICS
K061065 04/17/2006 FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 TECO DIAGNOSTICS
K051121 05/02/2005 DIRECT LDL CHOLESTEROL, MODEL L530-60H TECO DIAGNOSTICS
K051200 05/10/2005 HEMOGLOBIN A1C REAGENT SET TECO DIAGNOSTICS
K061419 05/22/2006 TECO MICROALBUMIN 2-1 COMBO STRIPS TECO DIAGNOSTICS
K052724 09/29/2005 TECO ISE REAGENT SET FOR CX SYSTEM TECO DIAGNOSTICS
K063701 12/13/2006 TECO HOMOCYSTEINE ENZYMATIC ASSAY TECO DIAGNOSTICS
K073370 11/30/2007 TC MATRIX CLINICAL CHEMISTRY ANALYZER TECO DIAGNOSTICS
K961629 04/26/1996 THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST TECO DIAGNOSTICS
K955438 11/08/1995 URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) TECO DIAGNOSTICS
K962019 05/23/1996 C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST TECO DIAGNOSTICS
K954977 10/16/1995 URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) TECO DIAGNOSTICS
K961864 05/14/1996 CSF/URINE TOTAL PROTEIN TECO DIAGNOSTICS
K962015 05/22/1996 RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST TECO DIAGNOSTICS
K100024 01/05/2010 TECO DIAGNOSTICS UTI DETECTION STRIPS TECO DIAGNOSTICS
K101673 06/15/2010 URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 TECO DIAGNOSTICS
K072548 09/10/2007 CREATINE KINASE LIQUID REAGENT, MODEL C519-440 TECO DIAGNOSTICS
K170118 01/13/2017 Scanostics UTI Check Application Test System Teco Diagnostics
K023297 10/02/2002 URS-1B (BLOOD TEST) TECO DIAGNOSTICS
K020175 01/17/2002 URS-IG (GLUCOSE TEST) TECO DIAGNOSTICS
K981106 03/26/1998 UREA NITROGEN (BUN) LIQUID REAGENT TECO DIAGNOSTICS
K981650 05/11/1998 AST/SGOT LIQUID REAGENT - KINETIC METHOD TECO DIAGNOSTICS
K051526 06/08/2005 URITEK-720+ URINE ANALYZER TECO DIAGNOSTICS
K131600 06/03/2013 URS-2GP (GLUCOSE PROTEIN) URINE STRIPS TECO DIAGNOSTICS
K042421 09/07/2004 URITEK 151 URINE ANALYZER, MODEL TC-151 TECO DIAGNOSTICS


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