Pantex, Div. Bio-Analysis, Inc.
Medical device manufacturer in Santa Monica, CA.
16510(k) clearances
0PMA approvals
0recalls
Device types
- CHP Radioimmunoassay, Estradiol 2
- CDZ Radioimmunoassay, Testosterones And… 2
- CEP Radioimmunoassay, Luteinizing Hormone 2
- JKC Radioimmunoassay, Dehydroepiandrosterone… 1
- CDX Radioimmunoassay, Total Thyroxine 1
- CGR Radioimmunoassay, Cortisol 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- JLS Radioimmunoassay, Progesterone 1
- JLX Radioimmunoassay, 17-Hydroxyprogesterone 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- CFT Radioimmunoassay, Prolactin (Lactogen) 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- NHG Enzyme Immunoassay, Cortisol, Salivary 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102841 | Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional | 05/08/2012SE |
| K942658 | Neoscreen Elisa TSHJLW · Traditional | 02/24/1995SE |
| K914107 | Prolactin Irma ImmunomagCFT · Traditional | 09/30/1991SE |
| K912804 | FSH Irma ImmunomagCGJ · Traditional | 08/12/1991SE |
| K911839 | Neonatal Blood Spot Test 17-HYDROXPROG Radio KitJLX · Traditional | 06/18/1991SE |
| K911050 | LH Irma ImmunomagCEP · Traditional | 04/12/1991SE |
| K910717 | Pantex Irma LH 1251 KitCEP · Traditional | 03/19/1991SE |
| K894049 | Immunocoat Progesterone Radioimmunoassay KitJLS · Traditional | 09/08/1989SE |
| K862483 | Pantex Fte Free Testosterone Radioimmunoassay KitCDZ · Traditional | 01/14/1987SE |
| K862447 | Pancoat T3 Uptake Coated Tube Radioimmunoassay KitKHQ · Traditional | 10/07/1986SE |
| K862336 | Pancoat Cortisol Coated Tube Radioimmunoassay KitCGR · Traditional | 09/25/1986SE |
| K854324 | Pancoat T4 Coated Tube Radioimmunoassay KitCDX · Traditional | 12/05/1985SE |
| K853866 | Pantex Direct Estradiol Coated Tube RadioimmunoassCHP · Traditional | 10/15/1985SE |
| K853865 | Pantex Direct Testosterone Coated Tube RadioimmunoCDZ · Traditional | 10/15/1985SE |
| K853867 | Pantex Direct Dhea-S Coated Tube RadioimmunoassayJKC · Traditional | 10/04/1985SE |
| K810204 | 17B EstradiolCHP · Traditional | 03/27/1981SE |