Biotecx Laboratories, Inc.
Medical device manufacturer in Houston, TX.
15510(k) clearances
0PMA approvals
0recalls
Device types
- JLS Radioimmunoassay, Progesterone 2
- CGR Radioimmunoassay, Cortisol 2
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
- JOM Plethysmograph, Photoelectric, Pneumatic Or… 1
- JKC Radioimmunoassay, Dehydroepiandrosterone… 1
- CGI Radioimmunoassay, Estriol 1
- CHP Radioimmunoassay, Estradiol 1
- KQN Radioassay, Angiotensin Converting Enzyme 1
- JMX Ninhydrin, Nitrogen (Amino-Nitrogen) 1
- KHQ Radioassay, Triiodothyronine Uptake 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K982298 | Opticoat T4 Eia KitKLI · Traditional | 02/03/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | 12/22/1998SE |
| K895407 | Cortisol Clasp-Bead Eia KitCGR · Traditional | 10/19/1989SE |
| K893620 | T3 Clasp-Bead Eia KitCDP · Traditional | 08/11/1989SE |
| K892853 | T4 Clasp-Bead Eia KitKLI · Traditional | 05/22/1989SE |
| K883765 | TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional | 10/31/1988SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | 04/13/1987SE |
| K863188 | HPL Ria KitJMX · Traditional | 09/25/1986SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | 03/17/1986SE |
| K851540 | Estradiol Direct Ria KitCHP · Traditional | 06/06/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | 02/01/1985SE |
| K842957 | Coritsol Premix Ria KitCGR · Traditional | 09/14/1984SE |
| K842555 | Dhea-S Direct Ria KitJKC · Traditional | 08/07/1984SE |
| K841333 | Progesterone Direct Ria Kit-RadioimmJLS · Traditional | 05/02/1984SE |
| K780761 | Electro-PlethysmographJOM · Traditional | 06/30/1978SE |