Tech Intl. Co.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Tech Intl. Co.” (first 1990, latest 1996), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| CEI | Uranyl Acetate/Zinc Acetate, Sodium | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CJD | Nitrosalicylate Reduction, Amylase | 1 | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 | 1 |
| CKE | Acid Phosphatase, Thymolphthale Inmonophosphate | 1 | 1 |
| DIH | Colorimetry, Cholinesterase | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Tech Intl. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915704 | AMYLASE (KINETIC) REAGENT SET | CJD | 1996-06-28 | 1675 |
| K915705 | ACID PHOSPHATASE REAGENT SET | CKE | 1992-02-27 | 90 |
| K915707 | AMMONIA REAGENT SET | JIF | 1992-02-26 | 89 |
| K914158 | URIC ACID REAGENT SET | KNK | 1992-02-21 | 157 |
| K915706 | LIPASE REAGENT SET | CET | 1992-02-18 | 81 |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | JFJ | 1992-01-30 | 62 |
| K914160 | CHOLESTEROL REGEANT SET | CHH | 1992-01-30 | 135 |
| K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | CGS | 1992-01-27 | 59 |
| K914159 | GLUCOSE REAGENT SET | CGA | 1992-01-27 | 132 |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | CEO | 1992-01-22 | 54 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tech Intl. Co..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Tech Intl. Co. (a text match, not an official crosswalk):
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-Co, Inc. (36 510(k)s)
- Tech-Neal Scientific, Inc. (20 510(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 Intl. Co.?
FDA lists 13 510(k) clearances under the applicant name “Tech Intl. Co.” (first 1990, latest 1996), across 13 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 Intl. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tech Intl. Co. is 89 days.
Which FDA product codes appear under Tech Intl. Co.?
The most frequent FDA product codes under this applicant name are CEI (Uranyl Acetate/Zinc Acetate, Sodium, 1); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 1); CET (Olive Oil Emulsion (Turbidimetric), Lipase, 1).
Next steps
- See all 13 Tech Intl. Co. clearances with predicates and recalls
- Run predicate analysis for product code CEI, Tech Intl. Co.'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.