Diagnostics Biochem Canada, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Diagnostics Biochem Canada, Inc.” (first 1978, latest 2003), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| CGF | Radioimmunoassay, Estrone | 1 | 1 |
| CIZ | Radioimmunoassay, Androstenedione | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
Review panels
Most recent Diagnostics Biochem Canada, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | CDZ | 2003-08-18 | 161 |
| K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | CDZ | 2002-02-08 | 53 |
| K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | CGF | 1987-01-09 | 18 |
| K832297 | HYDROXYPROGESTERONE-17 | JLS | 1983-09-01 | 50 |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | CIZ | 1980-10-31 | 99 |
| K781310 | HUMAN CHORIONIC GONADO.-BETA RIA KIT | JHI | 1978-08-31 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnostics Biochem Canada, 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.
- Diagnostics Direct, LLC (1 510(k)s)
- Diagnostics Intl. (1 510(k)s)
- Diagnostics Stago S.A.S. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostics Biochem Canada, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Diagnostics Biochem Canada, Inc.” (first 1978, latest 2003), across 5 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 Diagnostics Biochem Canada, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostics Biochem Canada, Inc. is 52 days.
Which FDA product codes appear under Diagnostics Biochem Canada, Inc.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); CGF (Radioimmunoassay, Estrone, 1); CIZ (Radioimmunoassay, Androstenedione, 1).
Next steps
- See all 6 Diagnostics Biochem Canada, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Diagnostics Biochem Canada, 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.