Teco Diagnostics
Medical device manufacturer in Anaheim, CA.
55510(k) clearances
0PMA approvals
9recalls
Device types
- JIL Method, Enzymatic, Glucose (Urinary… 8
- JHI Visual, Pregnancy Hcg, Prescription Use 4
- LCP Assay, Glycosylated Hemoglobin 2
- KQO Automated Urinalysis System 2
- JMT Diazo (Colorimetric), Nitrite (Urinary… 2
- CDQ Urease And Glutamic Dehydrogenase, Urea… 2
- JFY Enzymatic Method, Creatinine 2
- JIR Indicator Method, Protein Or Albumin… 2
- KHS Enzymatic, Carbon-Dioxide 2
- JFJ Catalytic Methods, Amylase 2
- JJB Azo-Dyes, Colorimetric, Bilirubin & Its… 1
- JRE Refractometer For Clinical Use 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- CEK Biuret (Colorimetric), Total Protein 1
- DHR System, Test, Rheumatoid Factor 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- CET Olive Oil Emulsion (Turbidimetric), Lipase 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- DNK Thin Layer Chromatography, Morphine 1
- JMK Acid, Alpha-Ketobutyric And Nadh (U.V.)… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | 09/21/2017SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | 07/21/2017SE |
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | 06/01/2017SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | 07/22/2016SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | 03/07/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | 05/29/2014SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | 10/04/2011SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | 02/17/2011SE |
| K101673 | Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, URS-10JIL · Traditional | 02/04/2011SE |
| K073370 | TC Matrix Clinical Chemistry AnalyzerJJE · Traditional | 05/08/2008SE |
| K072548 | Creatine Kinase Liquid Reagent, Model C519-440CGS · Traditional | 04/18/2008SE |
| K063701 | Teco Homocysteine Enzymatic AssayLPS · Traditional | 04/11/2007SE |
| K061419 | Teco Microalbumin 2-1 Combo StripsJIR · Traditional | 01/26/2007SE |
| K061065 | Fecal Occult Blood Card Test, Model F735-A, Fecal Occult Blood Card Kit, Model F735-25KHE · Traditional | 07/14/2006SE |
| K060364 | Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation TubeJKA · Traditional | 06/15/2006SE |
| K060120 | Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional | 03/27/2006SE |
| K052724 | Teco Ise Reagent Set for CX SystemJGS · Traditional | 12/14/2005SE |
| K051526 | URITEK-720+ Urine AnalyzerKQO · Traditional | 08/16/2005SE |
| K051200 | Hemoglobin A1C Reagent SetLCP · Traditional | 08/08/2005SE |
| K051121 | Direct LDL Cholesterol, Model L530-60HMRR · Traditional | 08/08/2005SE |
| K050823 | Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional | 07/26/2005SE |
| K042421 | Uritek 151 Urine Analyzer, Model TC-151KQO · Traditional | 05/09/2005SE |
| K040920 | Amylase Liquid Reagent, Model A532-200JFJ · Special | 05/10/2004SE |
| K023297 | URS-1B (Blood Test)JIO · Traditional | 03/06/2003SE |
| K020175 | Urs-Ig (Glucose Test)JIL · Traditional | 03/21/2002SE |
| K010239 | Cocaine Dipstick Test, Model D747-ADIO · Traditional | 06/25/2001SE |
| K003987 | URS-1K (Ketone Tesst)JIN · Traditional | 04/26/2001SE |
| K000102 | Glucose (Hexokinase) Liquid Reagent, Model G518-150CFR · Special | 02/08/2000SE |
| K000067 | Alkaline Phosphatase Liquid Reagent-Kinetic, Models A504-150 and A504-500HCJE · Special | 01/20/2000SE |
| K981650 | Ast/Sgot Liquid Reagent - Kinetic MethodCIT · Traditional | 06/29/1998SE |
| K981106 | Urea Nitrogen (Bun) Liquid ReagentCDQ · Traditional | 04/16/1998SE |
| K970579 | One Step Morphine Card TestDNK · Traditional | 07/03/1997SE |
| K970548 | One Step Marijuana Card TestLDJ · Traditional | 07/03/1997SE |
| K970250 | ClinistripJIL · Traditional | 04/08/1997SE |
| K970120 | Bile Acids Reagent SetKWW · Traditional | 03/24/1997SE |
| K970124 | Lipase Reagent Set (Colipase Method)CET · Traditional | 03/06/1997SE |
| K964536 | One-Step Dipstick Pregnancy TestJHI · Traditional | 02/11/1997SE |
| K964462 | One-Step Urine/Serum Comno Pregnancy Dipstick TestJHI · Traditional | 02/11/1997SE |
| K964461 | One -Step Urine/Serum Combo Pregnancy Card TestJHI · Traditional | 02/11/1997SE |
| K962019 | C-Reactive Protein (Crp):A Latex Slide TestDCK · Traditional | 11/25/1996SE |
| K962015 | Rheumatoid Factor (RF) Reagenti a Latex Slide TestDHR · Traditional | 11/25/1996SE |
| K961864 | Csf/Urine Total ProteinCEK · Traditional | 10/24/1996SE |
| K961629 | Thyroid Stiumlating Hormone (Tsh-Beads Assay) TestJLW · Traditional | 09/11/1996SE |
| K954977 | Urine Reagents STRIPS-8 Parameters (Modification)JRE · Traditional | 03/11/1996SE |
| K955438 | Urine Reagent STRIPS-3 Parameters (Modification)JIR · Traditional | 01/29/1996SE |
| K943436 | Urine Reagent STRIPS-8 ParametersJJB · Traditional | 04/24/1995SE |
| K942648 | In Vitro Diagnostic Urine Reagent Strips SetJIL · Traditional | 03/24/1995SE |
| K942735 | Carbon Dioxide (C02)KHS · Traditional | 03/20/1995SE |
| K941427 | Serum @-Hydroxybutyrate Dehydrogenase (HBDH)JMK · Traditional | 03/13/1995SE |
| K936245 | Multi Analyte Linearity SetJJY · Traditional | 10/04/1994SE |
| K940469 | Urine Reagent STRIP-3 ParametersJIL · Traditional | 09/09/1994SE |
| K936031 | One Step Pregnancy TestJHI · Traditional | 04/15/1994SE |
| K931183 | GlycohemoglobinLCP · Traditional | 11/05/1993SE |
| K931080 | Amylase Reagent Set (Kinetic)JFJ · Traditional | 11/05/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0512-2012 | Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise…This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has… | 10/14/2011Terminated |
| Z-0511-2012 | Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise…This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has… | 10/14/2011Terminated |
| Z-0583-2011 | NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |
| Z-0582-2011 | McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |
| Z-0581-2011 | Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |
| Z-0580-2011 | Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |
| Z-0579-2011 | Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |
| Z-0578-2011 | Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |
| Z-0577-2011 | Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | 10/01/2010Terminated |