Biocircuits Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Biocircuits Corp.” (first 1995, latest 1998), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 131 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHO | Fluorometer, For Clinical Use | 1 | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 | 1 |
Review panels
- Clinical Chemistry (7)
- Immunology (1)
Most recent Biocircuits Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981634 | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS | LTJ | 1998-10-13 | 158 |
| K980819 | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS | CEC | 1998-04-03 | 31 |
| K963770 | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS | JJY | 1996-12-05 | 77 |
| K961566 | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS | JLW | 1996-11-18 | 209 |
| K961792 | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS | DHA | 1996-08-21 | 104 |
| K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | KHO | 1995-11-22 | 160 |
| K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE | KLI | 1995-11-20 | 97 |
| K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES | KLI | 1995-11-20 | 158 |
Recalls
openFDA lists no recalls under a recalling firm named Biocircuits Corp..
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 Biocircuits Corp.?
FDA lists 8 510(k) clearances under the applicant name “Biocircuits Corp.” (first 1995, latest 1998), across 7 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 Biocircuits Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biocircuits Corp. is 131 days.
Which FDA product codes appear under Biocircuits Corp.?
The most frequent FDA product codes under this applicant name are KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, 2); CEC (Radioimmunoassay, Free Thyroxine, 1); DHA (System, Test, Human Chorionic Gonadotropin, 1).
Next steps
- See all 8 Biocircuits Corp. clearances with predicates and recalls
- Run predicate analysis for product code KLI, Biocircuits Corp.'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.