Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teco Diagnostics — Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
283 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | 2017-09-21 | 251 | 0 |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDE | Teco Diagnostics | 2015-07-24 | 431 | 0 |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | 2014-05-29 | 360 | 0 |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Teco Diagnostics | 2011-10-04 | 158 | 0 |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Teco Diagnostics | 2011-02-17 | 408 | 0 |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODEL | Teco Diagnostics | 2011-02-04 | 234 | 0 |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | 2008-05-08 | 160 | 0 |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Teco Diagnostics | 2008-04-18 | 221 | 0 |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Teco Diagnostics | 2007-04-11 | 119 | 0 |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Teco Diagnostics | 2007-01-26 | 249 | 0 |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLO | Teco Diagnostics | 2006-07-14 | 88 | 0 |
| K060364 | VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VAC | Teco Diagnostics | 2006-06-15 | 122 | 0 |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | 2006-03-27 | 69 | 0 |
| K052724 | TECO ISE REAGENT SET FOR CX SYSTEM | Teco Diagnostics | 2005-12-14 | 76 | 0 |
| K051526 | URITEK-720+ URINE ANALYZER | Teco Diagnostics | 2005-08-16 | 69 | 0 |
| K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H | Teco Diagnostics | 2005-08-08 | 98 | 0 |
| K051200 | HEMOGLOBIN A1C REAGENT SET | Teco Diagnostics | 2005-08-08 | 90 | 0 |
| K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | Teco Diagnostics | 2005-07-26 | 117 | 0 |
| K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | Teco Diagnostics | 2005-05-09 | 244 | 0 |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | 2004-05-10 | 32 | 0 |
| K023297 | URS-1B (BLOOD TEST) | Teco Diagnostics | 2003-03-06 | 155 | 0 |
| K020175 | URS-IG (GLUCOSE TEST) | Teco Diagnostics | 2002-03-21 | 63 | 0 |
| K010239 | COCAINE DIPSTICK TEST, MODEL D747-A | Teco Diagnostics | 2001-06-25 | 151 | 0 |
| K003987 | URS-1K (KETONE TESST) | Teco Diagnostics | 2001-04-26 | 121 | 0 |
| K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 | Teco Diagnostics | 2000-02-08 | 26 | 0 |
| K000067 | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 | Teco Diagnostics | 2000-01-20 | 10 | 0 |
| K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | Teco Diagnostics | 1998-06-29 | 49 | 0 |
| K981106 | UREA NITROGEN (BUN) LIQUID REAGENT | Teco Diagnostics | 1998-04-16 | 21 | 0 |
| K970579 | ONE STEP MORPHINE CARD TEST | Teco Diagnostics | 1997-07-03 | 139 | 0 |
| K970548 | ONE STEP MARIJUANA CARD TEST | Teco Diagnostics | 1997-07-03 | 141 | 0 |
| K970250 | CLINISTRIP | Teco Diagnostics | 1997-04-08 | 76 | 0 |
| K970120 | BILE ACIDS REAGENT SET | Teco Diagnostics | 1997-03-24 | 69 | 0 |
| K970124 | LIPASE REAGENT SET (COLIPASE METHOD) | Teco Diagnostics | 1997-03-06 | 51 | 0 |
| K964536 | ONE-STEP DIPSTICK PREGNANCY TEST | Teco Diagnostics | 1997-02-11 | 91 | 0 |
| K964462 | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST | Teco Diagnostics | 1997-02-11 | 96 | 0 |
| K964461 | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST | Teco Diagnostics | 1997-02-11 | 96 | 0 |
| K962019 | C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST | Teco Diagnostics | 1996-11-25 | 186 | 0 |
| K962015 | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST | Teco Diagnostics | 1996-11-25 | 187 | 0 |
| K961864 | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | 1996-10-24 | 163 | 0 |
| K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST | Teco Diagnostics | 1996-09-11 | 138 | 0 |
| K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | Teco Diagnostics | 1996-03-11 | 147 | 0 |
| K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | Teco Diagnostics | 1996-01-29 | 82 | 0 |
| K943436 | URINE REAGENT STRIPS-8 PARAMETERS | Teco Diagnostics | 1995-04-24 | 280 | 0 |
| K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET | Teco Diagnostics | 1995-03-24 | 294 | 0 |
| K942735 | CARBON DIOXIDE (C02) | Teco Diagnostics | 1995-03-20 | 283 | 0 |
| K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | Teco Diagnostics | 1995-03-13 | 354 | 0 |
| K936245 | MULTI ANALYTE LINEARITY SET | Teco Diagnostics | 1994-10-04 | 278 | 0 |
| K940469 | URINE REAGENT STRIP-3 PARAMETERS | Teco Diagnostics | 1994-09-09 | 219 | 0 |
| K936031 | ONE STEP PREGNANCY TEST | Teco Diagnostics | 1994-04-15 | 119 | 0 |
| K931183 | GLYCOHEMOGLOBIN | Teco Diagnostics | 1993-11-05 | 241 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda