Technostics Intl.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Technostics Intl.” (first 1986, latest 1986), across 19 product codes in 1 review panel. Median 510(k) review time under this name: 19 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFD | Sulfophosphovanillin, Colorimetry, Total Lipids | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (21)
Most recent Technostics Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K855188 | CPK (UV) REAGENT KIT | JHS | 1986-03-05 | 69 |
| K860111 | URIC ACID REAGENT SET | LFQ | 1986-02-19 | 37 |
| K855190 | MAGNESIUM REAGENT SET | JGJ | 1986-02-18 | 54 |
| K860110 | GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET | CKA | 1986-02-11 | 29 |
| K860109 | ENZYMATIC UREA NITROGEN REAGENT SET | CDQ | 1986-02-06 | 24 |
| K860112 | TOTAL LIPIDS REAGENT SET | CFD | 1986-01-24 | 11 |
| K855185 | GLUCOSE REAGENT SET | CGE | 1986-01-22 | 27 |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | CFJ | 1986-01-21 | 26 |
| K855195 | DIRECT & TOTAL BILIRUBIN SET | CIG | 1986-01-14 | 19 |
| K855194 | GLUCOSE OXIDASE REAGENT SET | CGA | 1986-01-14 | 19 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Technostics Intl..
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 Technostics Intl.?
FDA lists 21 510(k) clearances under the applicant name “Technostics Intl.” (first 1986, latest 1986), across 19 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Technostics Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Technostics Intl. is 19 days.
Which FDA product codes appear under Technostics Intl.?
The most frequent FDA product codes under this applicant name are CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 2); JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1).
Next steps
- See all 21 Technostics Intl. clearances with predicates and recalls
- Run predicate analysis for product code CFJ, Technostics Intl.'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.