Biocircuits Corp.
Medical device manufacturer in Sunnyvale, CA.
8510(k) clearances
0PMA approvals
0recalls
Device types
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 2
- KHO Fluorometer, For Clinical Use 1
- DHA System, Test, Human Chorionic Gonadotropin 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CEC Radioimmunoassay, Free Thyroxine 1
- LTJ Prostate-Specific Antigen (Psa) For… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981634 | Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa…LTJ · Traditional | 10/13/1998SE |
| K980819 | Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios ControlsCEC · Traditional | 04/03/1998SE |
| K963770 | Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay ControlsJJY · Traditional | 12/05/1996SE |
| K961566 | Biocircuits Ios TSH Test Cartridges/Thyroid ControlsJLW · Traditional | 11/18/1996SE |
| K961792 | Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay ControlsDHA · Traditional | 08/21/1996SE |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | 11/22/1995SE |
| K953837 | Biocircuits Ios T4 Test CartridgeKLI · Traditional | 11/20/1995SE |
| K952751 | Biocircuits Ios T4/TU Test CartridgesKLI · Traditional | 11/20/1995SE |