Diatech, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Diatech, Inc.” (first 1984, latest 1988), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 5 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 3 | 3 |
| KQJ | System, Fibrinogen Determination | 2 | 2 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 | 1 |
| GIR | Reagent, Russel Viper Venom | 1 | 1 |
| GIS | Test, Fibrinogen | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (16)
Most recent Diatech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881685 | FIBRINOGENTEST-O | GIS | 1988-08-09 | 112 |
| K854938 | COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. | JPA | 1986-03-12 | 92 |
| K854090 | DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT | JPA | 1986-01-06 | 91 |
| K854089 | DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT | JPA | 1986-01-06 | 91 |
| K842286 | DIA T1, T2 & T3 | JPK | 1984-09-11 | 90 |
| K841523 | OWREN'S VERONAL BUFFERR | JPA | 1984-06-01 | 50 |
| K841462 | HEPARIN COAGULATION CONTROL PLASMA 1- | JPA | 1984-06-01 | 53 |
| K841366 | DIA FIBRIN | KQJ | 1984-06-01 | 60 |
| K841365 | DIA REPTIN | GIR | 1984-06-01 | 60 |
| K841461 | COAGULATION CONTROL PLASMA LEVEL 1/2/3 | GGP | 1984-05-02 | 23 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diatech, 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.
- Diatech Diagnostica , Ltd. (3 510(k)s)
- Diatech Diagnostics,Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diatech, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Diatech, Inc.” (first 1984, latest 1988), across 10 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 Diatech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diatech, Inc. is 60 days.
Which FDA product codes appear under Diatech, Inc.?
The most frequent FDA product codes under this applicant name are JPA (System, Multipurpose For In Vitro Coagulation Studies, 5); GGP (Test, Qualitative And Quantitative Factor Deficiency, 3); KQJ (System, Fibrinogen Determination, 2).
Next steps
- See all 17 Diatech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPA, Diatech, 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, 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.