Tech-Co, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Tech-Co, Inc.” (first 1986, latest 1996), across 33 product codes in 2 review panels. Median 510(k) review time under this name: 40 days. 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 | 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 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tech-Neal Scientific, Inc. (20 510(k)s)
- Tech Intl. Co. (13 510(k)s)
- Tech-Cons Ltd., Intl. (6 510(k)s)
- Tech America Diagnostics (3 510(k)s)
- Tech Dyne Group (1 510(k)s)
- Tech Engineering, Inc. (1 510(k)s)
- Tech-Image CO., LTD. (1 510(k)s)
- Tech-Pro, Inc. (1 510(k)s)
- Tech Vend Marketing (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tech-Co, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Tech-Co, Inc.” (first 1986, latest 1996), across 33 product codes in 2 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 Tech-Co, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tech-Co, Inc. is 40 days.
Which FDA product codes appear under Tech-Co, Inc.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CIG (Diazo Colorimetry, Bilirubin, 2); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.