Monobind
Medical device manufacturer in Lake Forest, CA.
23510(k) clearances
0PMA approvals
0recalls
Device types
- CDP Radioimmunoassay, Total Triiodothyronine 3
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 3
- CDX Radioimmunoassay, Total Thyroxine 2
- KHQ Radioassay, Triiodothyronine Uptake 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 2
- CFT Radioimmunoassay, Prolactin (Lactogen) 2
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 2
- CEP Radioimmunoassay, Luteinizing Hormone 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- LCS Radioimmunoassay, Digoxin (125-I) 1
- JNL Immunochemical, Thyroglobulin Autoantibody 1
- DDC Thyroglobulin, Antigen, Antiserum, Control 1
- CEC Radioimmunoassay, Free Thyroxine 1
- CDZ Radioimmunoassay, Testosterones And… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test SystemCDZ · Traditional | 07/20/2018SE |
| K063437 | Accubind Neo-Tsh Microwell Elisa, Model 3425-300JLW · Traditional | 04/04/2008SE |
| K030860 | Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional | 08/22/2003SE |
| K020548 | Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300CEC · Traditional | 04/05/2002SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | 02/04/1998SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | 09/02/1997SE |
| K971835 | Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional | 07/03/1997SE |
| K971834 | Anti-Thyroid Peroxidase (Tpo) Microplate ElisaJNL · Traditional | 07/03/1997SE |
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | 06/24/1997SE |
| K971780 | Thyrotropin(Tsh) ElisaJLW · Traditional | 06/24/1997SE |
| K971779 | Total TRIIODOTHYRONINE(T3) Microplate EiaCDP · Traditional | 06/16/1997SE |
| K971709 | Total Throxine Microplate EIA(225-300)KLI · Traditional | 06/16/1997SE |
| K926345 | Triodothyronine (TC) Coated Tube RiaCDP · Traditional | 02/25/1993SE |
| K922353 | Digoxin Coated Tube RiaLCS · Traditional | 08/24/1992SE |
| K921935 | Thyroxine (T4) Coated Tube RiaCDX · Traditional | 07/07/1992SE |
| K854958 | HCG Ria Test SystemJHI · Traditional | 01/28/1986SE |
| K830412 | Radioimmunoassay Test System PRLCFT · Traditional | 04/05/1983SE |
| K820760 | LH Radioimmunoassay Test SystemCEP · Traditional | 04/16/1982SE |
| K820048 | FSH Radioimmunoassay Test SystemCGJ · Traditional | 02/04/1982SE |
| K780361 | T3 Uptake TestKHQ · Traditional | 03/22/1978SE |
| K771222 | TSH Ria Test SystemJLW · Traditional | 08/04/1977SE |
| K771221 | T4 Ria Test SystemCDX · Traditional | 08/04/1977SE |
| K771220 | T3 Ria Test SystemCDP · Traditional | 08/04/1977SE |