Biochemical Diagnostic, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biochemical Diagnostic, Inc.” (first 1984, latest 2012), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 | 1 | 81 |
| 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | 2 | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Toxicology (3)
- Clinical Chemistry (1)
- Immunology (1)
Most recent Biochemical Diagnostic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | DIF | 2012-07-03 | 81 |
| K050328 | PREGNANCY-SKREEN | JJX | 2005-03-29 | 48 |
| K925586 | DETECTABUSE(TM) | DIF | 1992-12-28 | 54 |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | DBL | 1991-09-10 | 364 |
| K841831 | CANNU-SKREEN-PRELIMINARY | DKE | 1984-07-06 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Biochemical Diagnostic, 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.
- Biochemical Trade, Inc. (20 510(k)s)
- Biochemical Diagnostics, Inc. (2 510(k)s)
- Biochemical Sciences, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biochemical Diagnostic, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Biochemical Diagnostic, Inc.” (first 1984, latest 2012), across 4 product codes in 3 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 Biochemical Diagnostic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biochemical Diagnostic, Inc. is 64 days.
Which FDA product codes appear under Biochemical Diagnostic, Inc.?
The most frequent FDA product codes under this applicant name are DIF (Drug Mixture Control Materials, 2); DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, 1); DKE (Reagents, Test, Tetrahydrocannabinol, 1).
Next steps
- See all 5 Biochemical Diagnostic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIF, Biochemical Diagnostic, 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.