Serono-Baker Diagnostics, Inc.
Medical device manufacturer in Allentown, PA.
23510(k) clearances
0PMA approvals
0recalls
Device types
- CHP Radioimmunoassay, Estradiol 4
- DBF Ferritin, Antigen, Antiserum, Control 2
- JLS Radioimmunoassay, Progesterone 2
- CGR Radioimmunoassay, Cortisol 2
- CDZ Radioimmunoassay, Testosterones And… 2
- JJE Analyzer, Chemistry (Photometric… 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- CEP Radioimmunoassay, Luteinizing Hormone 1
- CFT Radioimmunoassay, Prolactin (Lactogen) 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- CEC Radioimmunoassay, Free Thyroxine 1
- KXT Enzyme Immunoassay, Digoxin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K924257 | Testosterone Serozyme(Tm) Enzyme ImmunoassayCDZ · Traditional | 11/30/1992SE |
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | 03/02/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | 01/17/1992SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | 11/19/1991SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | 10/23/1991SE |
| K911912 | SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)KHQ · Traditional | 09/18/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | 08/16/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | 05/28/1991SE |
| K910837 | Sri TSH Immunenzymetric AssayJLW · Traditional | 05/24/1991SE |
| K910737 | Sri T3 Immoenzymetric AssayCDP · Traditional | 05/01/1991SE |
| K911175 | Sri Ferritin Immoenzymetric Assay(Mag Solid-Phase)DBF · Traditional | 04/05/1991SE |
| K903975 | Serozyme Cortisol Test KitCGR · Traditional | 01/23/1991SE |
| K896145 | Estradiol Serozyme Immunoenzymetric AssayCHP · Traditional | 12/27/1989SE |
| K894175 | Sri Human Chorionic Gonadotropin Immunoenz AssayJHI · Traditional | 12/19/1989SE |
| K895380 | SR1 Prolactin (PRL Immunoenzymetric AssayCFT · Traditional | 10/17/1989SE |
| K893605 | Sri Luteinizing Hormone Immunoenzymetric AssayCEP · Traditional | 06/20/1989SE |
| K892706 | SR1 (FSH) Immunoenzymetric AssayCGJ · Traditional | 06/09/1989SE |
| K890645 | Estradiol Maiaclone Radioimmunoassay KitCHP · Traditional | 03/08/1989SE |
| K884794 | Progesterone Serozyme Immunoenzymetric AssayJLS · Traditional | 02/02/1989SE |
| K884683 | Ferritin Serozyme Immunoenzymetric AssayDBF · Traditional | 12/27/1988SE |
| K883539 | SR1 System Automated Photometric AnalyzerJJE · Traditional | 10/31/1988SE |