Teco Diagnostics: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Teco Diagnostics” (first 1993, latest 2017), across 37 product codes in 4 review panels. Median 510(k) review time under this name: 141 days. Since 2017 the median was 251 days, against 199 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 360 |
| 2015 | 1 | 431 |
| 2016 | 2 | 162 |
| 2017 | 3 | 251 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Teco Diagnostics took a median 251 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 199 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 8 | 8 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| JFJ | Catalytic Methods, Amylase | 2 | 2 |
| JFY | Enzymatic Method, Creatinine | 2 | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 2 | 2 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 2 | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 2 |
| KQO | Automated Urinalysis System | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
Plus 27 more product codes.
Review panels
- Clinical Chemistry (45)
- Hematology (4)
- Clinical Toxicology (4)
- Immunology (2)
Most recent Teco Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170118 | Scanostics UTI Check Application Test System | JMT | 2017-09-21 | 251 |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | JFY | 2017-07-21 | 414 |
| K170200 | Carbon Dioxide Reagent Set | KHS | 2017-06-01 | 129 |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | JIL | 2016-07-22 | 163 |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | JFY | 2016-03-07 | 160 |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | JIL | 2015-07-24 | 431 |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | JIL | 2014-05-29 | 360 |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | DIC | 2011-10-04 | 158 |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | JMT | 2011-02-17 | 408 |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | JIL | 2011-02-04 | 234 |
45 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2011-10-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Teco Diagnostics?
FDA lists 55 510(k) clearances under the applicant name “Teco Diagnostics” (first 1993, latest 2017), across 37 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Teco Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teco Diagnostics is 141 days. Since 2017: 251 days, versus 199 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Teco Diagnostics?
The most frequent FDA product codes under this applicant name are JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 8); JHI (Visual, Pregnancy Hcg, Prescription Use, 4); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 2).
Next steps
- See all 55 Teco Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JIL, Teco Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.