Medical Device Manufacturer · US , Placentia , CA

Teco Diagnostics

51 submissions · 51 cleared · Since 1993
51
Total
51
Cleared
0
Denied

Teco Diagnostics — FDA 510(k) Submissions

Teco Diagnostics has submitted 51 FDA 510(k) premarket notifications since 1993, of which 51 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Method, Enzymatic, Glucose (urinary, Non-quantitative), Visual, Pregnancy Hcg, Prescription Use, Assay, Glycosylated Hemoglobin, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Indicator Method, Protein Or Albumin (urinary, Non-quant.) . Use the specialty filter in the sidebar to narrow results.

51 devices
1–25 of 51
Scanostics UTI Check Application Test System
K170118 · JMT Diazo (colorimetric),... · Chemistry
Sep 2017 251d
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
K141289 · JIL Method, Enzymatic,... · Chemistry
Jul 2015 431d
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · JIL Method, Enzymatic,... · Chemistry
May 2014 360d
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K111206 · DIC Alcohol Dehydrogenase,... · Chemistry
Oct 2011 158d
TECO DIAGNOSTICS UTI DETECTION STRIPS
K100024 · JMT Diazo (colorimetric),... · Chemistry
Feb 2011 408d
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · JIL Method, Enzymatic,... · Chemistry
Feb 2011 234d
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K073370 · JJE Analyzer, Chemistry... · Chemistry
May 2008 160d
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · CGS Nad Reduction/nadh... · Chemistry
Apr 2008 221d
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K063701 · LPS Urinary Homocystine... · Chemistry
Apr 2007 119d
TECO MICROALBUMIN 2-1 COMBO STRIPS
K061419 · JIR Indicator Method, Protein... · Chemistry
Jan 2007 249d
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · KHE Reagent, Occult Blood · Hematology
Jul 2006 88d
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · JKA Tubes, Vials, Systems,... · Chemistry
Jun 2006 122d
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
K060120 · CDQ Urease And Glutamic... · Chemistry
Mar 2006 69d
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · JGS Electrode, Ion Specific,... · Chemistry
Dec 2005 76d
URITEK-720+ URINE ANALYZER
K051526 · KQO Automated Urinalysis System · Chemistry
Aug 2005 69d
DIRECT LDL CHOLESTEROL, MODEL L530-60H
K051121 · MRR System, Test, Low... · Chemistry
Aug 2005 98d
HEMOGLOBIN A1C REAGENT SET
K051200 · LCP Assay, Glycosylated... · Toxicology
Aug 2005 90d
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
K050823 · LBR Ldl & Vldl Precipitation,... · Chemistry
Jul 2005 117d
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421 · KQO Automated Urinalysis System · Chemistry
May 2005 244d
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · JFJ Catalytic Methods, Amylase · Chemistry
May 2004 32d
URS-1B (BLOOD TEST)
K023297 · JIO Blood, Occult,... · Chemistry
Mar 2003 155d
URS-IG (GLUCOSE TEST)
K020175 · JIL Method, Enzymatic,... · Chemistry
Mar 2002 63d
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · DIO Enzyme Immunoassay,... · Toxicology
Jun 2001 151d
URS-1K (KETONE TESST)
K003987 · JIN Nitroprusside, Ketones... · Chemistry
Apr 2001 121d
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · CFR Hexokinase, Glucose · Chemistry
Feb 2000 26d
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