Company ยท US
Teco Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2017. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KQO | Automated Urinalysis System | 12 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 8 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| JFJ | Catalytic Methods, Amylase | 2 |
| JFY | Enzymatic Method, Creatinine | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 2 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2017 | K170118 | Scanostics UTI Check Application Test System Teco Diagnostics | JMT |
| Jul 21, 2017 | K161527 | Teco Creatinine Enzymatic Reagent Kit Teco Diagnostics, Inc. | JFY |
| Jun 1, 2017 | K170200 | Carbon Dioxide Reagent Set Teco Diagnostics, Inc. | KHS |
| Jul 22, 2016 | K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM Teco Diagnostics, Inc. | JIL |
| Mar 7, 2016 | K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM Teco Diagnostics, Inc. | JFY |
| Jul 24, 2015 | K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS Teco Diagnostics | JIL |
| May 29, 2014 | K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS Teco Diagnostics | JIL |
| Oct 4, 2011 | K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST Teco Diagnostics | DIC |
| Feb 17, 2011 | K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS Teco Diagnostics | JMT |
| Feb 4, 2011 | K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 Teco Diagnostics | JIL |
| May 8, 2008 | K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER Teco Diagnostics | JJE |
| Apr 18, 2008 | K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 Teco Diagnostics | CGS |
| Apr 11, 2007 | K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY Teco Diagnostics | LPS |
| Jan 26, 2007 | K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS Teco Diagnostics | JIR |
| Jul 14, 2006 | K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 Teco Diagnostics | KHE |
| Jun 15, 2006 | K060364 | VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE Teco Diagnostics | JKA |
| Mar 27, 2006 | K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM Teco Diagnostics | CDQ |
| Dec 14, 2005 | K052724 | TECO ISE REAGENT SET FOR CX SYSTEM Teco Diagnostics | JGS |
| Aug 16, 2005 | K051526 | URITEK-720+ URINE ANALYZER Teco Diagnostics | KQO |
| Aug 8, 2005 | K051200 | HEMOGLOBIN A1C REAGENT SET Teco Diagnostics | LCP |
| Aug 8, 2005 | K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H Teco Diagnostics | MRR |
| Jul 26, 2005 | K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR Teco Diagnostics | LBR |
| May 9, 2005 | K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 Teco Diagnostics | KQO |
| May 10, 2004 | K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 Teco Diagnostics | JFJ |
| Mar 6, 2003 | K023297 | URS-1B (BLOOD TEST) Teco Diagnostics | JIO |
| Mar 21, 2002 | K020175 | URS-IG (GLUCOSE TEST) Teco Diagnostics | JIL |
| Jun 25, 2001 | K010239 | COCAINE DIPSTICK TEST, MODEL D747-A Teco Diagnostics | DIO |
| Apr 26, 2001 | K003987 | URS-1K (KETONE TESST) Teco Diagnostics | JIN |
| Feb 8, 2000 | K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 Teco Diagnostics | CFR |
| Jan 20, 2000 | K000067 | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H Teco Diagnostics | CJE |
| Jun 29, 1998 | K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD Teco Diagnostics | CIT |
| Apr 16, 1998 | K981106 | UREA NITROGEN (BUN) LIQUID REAGENT Teco Diagnostics | CDQ |
| Jul 3, 1997 | K970579 | ONE STEP MORPHINE CARD TEST Teco Diagnostics | DNK |
| Jul 3, 1997 | K970548 | ONE STEP MARIJUANA CARD TEST Teco Diagnostics | LDJ |
| Apr 8, 1997 | K970250 | CLINISTRIP Teco Diagnostics | JIL |
| Mar 24, 1997 | K970120 | BILE ACIDS REAGENT SET Teco Diagnostics | KWW |
| Mar 6, 1997 | K970124 | LIPASE REAGENT SET (COLIPASE METHOD) Teco Diagnostics | CET |
| Feb 11, 1997 | K964536 | ONE-STEP DIPSTICK PREGNANCY TEST Teco Diagnostics | JHI |
| Feb 11, 1997 | K964462 | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST Teco Diagnostics | JHI |
| Feb 11, 1997 | K964461 | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST Teco Diagnostics | JHI |
| Nov 25, 1996 | K962019 | C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST Teco Diagnostics | DCK |
| Nov 25, 1996 | K962015 | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST Teco Diagnostics | DHR |
| Oct 24, 1996 | K961864 | CSF/URINE TOTAL PROTEIN Teco Diagnostics | CEK |
| Sep 11, 1996 | K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST Teco Diagnostics | JLW |
| Mar 11, 1996 | K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) Teco Diagnostics | JRE |
| Jan 29, 1996 | K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) Teco Diagnostics | JIR |
| Apr 24, 1995 | K943436 | URINE REAGENT STRIPS-8 PARAMETERS Teco Diagnostics | JJB |
| Mar 24, 1995 | K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET Teco Diagnostics | JIL |
| Mar 20, 1995 | K942735 | CARBON DIOXIDE (C02) Teco Diagnostics | KHS |
| Mar 13, 1995 | K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) Teco Diagnostics | JMK |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Teco Diagnostics Urine Reagent Strips (URS) 11 Parameters
URS-11-100G-001
510(K) number: K970250
Devise Listing number: D072377
Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a Terminated |
KQO | None listed |
| Jan 11, 2012 | Teco Diagnostics Urine Reagent Strips (URS) 10 Parameters
URS-l0-100W
510(K) number: K970250
Devise Listing number: D072377
Each device consists of 100 strips of Urine Reagent Strips 10 parameters
packed with a desi Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device ha Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip Urine Analyzer
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistr Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device ha Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has be Terminated |
KQO | None listed |
| Feb 4, 2006 | Teco Diagnostics Uritek TC-101Urine Analyzer, catalog number TC-101 Terminated |
KQO | None listed |