Tech-Co, Inc.: FDA clearances and approvals
Tech-Co, Inc. has 36 FDA 510(k) clearances (first 1986, latest 1996), across 33 product codes in 2 review panels. Median 510(k) review time: 40 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 | 1 |
Plus 23 more product codes.
Review panels
- Clinical Chemistry (35)
- Hematology (1)
Most recent Tech-Co, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | JHJ | 1996-06-28 | 1523 |
| K923376 | VISUAL HCG PREGNANCY TEST | JHI | 1992-10-01 | 84 |
| K920766 | T4 EIA BEAD ASSAY | CDX | 1992-04-17 | 58 |
| K920716 | DIRECT PREGNANCY TEST | JHJ | 1992-03-24 | 35 |
| K902574 | POTASSIUM REAGENT SET | CEJ | 1990-07-10 | 29 |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | JIY | 1990-05-17 | 44 |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | CKD | 1988-10-13 | 64 |
| K883683 | HEMOGLOBIN | GJZ | 1988-10-06 | 38 |
| K883386 | CHLORIDE | CHJ | 1988-10-06 | 57 |
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | CIQ | 1988-06-07 | 81 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tech-Co, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tech-Co, Inc. have?
Tech-Co, Inc. has 36 FDA 510(k) clearances (first 1986, latest 1996), across 33 product codes in 2 review panels.
How long does FDA take to clear Tech-Co, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tech-Co, Inc.'s cleared 510(k)s is 40 days.
What devices does Tech-Co, Inc. make?
Its most frequent FDA product codes are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CIG (Diazo Colorimetry, Bilirubin, 2); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2).
Has Tech-Co, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tech-Co, Inc. Related entities may recall under other names.
Next steps
- See all 36 Tech-Co, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Tech-Co, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.