Biosan Laboratories, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biosan Laboratories, Inc.” (first 1983, latest 1986), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| KEA | Resins, Ion-Exchange | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| HLX | Photostimulator, Ac-Powered | 1 | 1 |
| HOM | Screen, Tangent, Ac-Powered (Campimeter) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Clinical Toxicology (3)
- Ophthalmic (2)
- Immunology (1)
Most recent Biosan Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860642 | PHOTRON VISUAL FIELD ANALYZER | HOM | 1986-04-15 | 54 |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | HLX | 1985-11-01 | 50 |
| K832763 | TOBRAMYCIN REAGENT | KLB | 1984-03-23 | 220 |
| K833193 | RADIOIMMUNOASSAY, THYROID STIMU. HORMONE | JLW | 1984-02-04 | 138 |
| K834023 | BIO-SCIENCE LABORATORIES T4 REAGENT | CDX | 1984-01-24 | 63 |
| K833318 | NORMAL GOAT SERUM | DHX | 1984-01-03 | 99 |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | KEA | 1983-12-08 | 73 |
| K833192 | NORMAL URINE CONTROL | JJY | 1983-12-08 | 80 |
| K833191 | ABNORMAL URINE CONTROL | JJY | 1983-12-08 | 80 |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | KEA | 1983-11-03 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Biosan Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosan Laboratories, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biosan Laboratories, Inc.” (first 1983, latest 1986), across 8 product codes in 4 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 Biosan Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosan Laboratories, Inc. is 76 days.
Which FDA product codes appear under Biosan Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); KEA (Resins, Ion-Exchange, 2); CDX (Radioimmunoassay, Total Thyroxine, 1).
Next steps
- See all 10 Biosan Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Biosan Laboratories, 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.