Serono Diagnostics, Inc.
Medical device manufacturer in Washington, DC.
25510(k) clearances
0PMA approvals
0recalls
Device types
- CEP Radioimmunoassay, Luteinizing Hormone 3
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 2
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- CFT Radioimmunoassay, Prolactin (Lactogen) 2
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 1
- GKZ Counter, Differential Cell 1
- JKC Radioimmunoassay, Dehydroepiandrosterone… 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- JLS Radioimmunoassay, Progesterone 1
- JKD Radioimmunoassay, C-Peptides Of Proinsulin 1
- GQH Antigen, Cf (Including Cf Control)… 1
- LKT Respiratory Syncytial Virus, Antigen… 1
- CHP Radioimmunoassay, Estradiol 1
- LKI Antisera, Fluorescent, Chlamydia Spp. 1
- CIB Radioimmunoassay, Angiotensin I And Renin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K953598 | Series 9100 Plus Automated Differential Hematology AnalyzersGKZ · Traditional | 03/11/1996SE |
| K942051 | SR1 Dhea-S Enzyme ImmunoassayJKC · Traditional | 07/13/1994SE |
| K883085 | T3 Uptake Serozyme Enzyme Immuno Kt/Mag Solid PhasKHQ · Traditional | 09/09/1988SE |
| K882340 | LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaCEP · Traditional | 08/08/1988SE |
| K880388 | T3 Serozyme Enzymeimmunoassay Kit, Mag Solid PhaseCDP · Traditional | 03/03/1988SE |
| K874866 | T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid PhaseKLI · Traditional | 02/11/1988SE |
| K873431 | Progesterone Maia Radioimmuno Assay Kit Mag SLD PHJLS · Traditional | 10/20/1987SE |
| K873186 | LH Maiaclone Immunoradio. Assay Kit, Mag Solid PhaCEP · Traditional | 09/29/1987SE |
| K873400 | Prolactin Maiaclone Immunoradio. Kit, Mag Sol PhaCFT · Traditional | 09/25/1987SE |
| K872862 | PRL Serozyme Immunoenz. Assay Kit, Mag. Solid PhasCFT · Traditional | 09/18/1987SE |
| K873033 | HCG Serozyme Immunoenzym Assay Kit/Mag Solid PhaseJHI · Traditional | 09/14/1987SE |
| K872727 | LH Serozyme Immunoenzymetric Assay Kit, Mag. PhaseCEP · Traditional | 08/05/1987SE |
| K872897 | TSH Serozyme Immunoenzymetric Kit, Mag. Solid Pha.JLW · Traditional | 07/31/1987SE |
| K872627 | FSH Serozyme Immunoenzymetric Assay Kit/Mag Sep PHCGJ · Traditional | 07/21/1987SE |
| K870946 | Monabrite Chlamydia Trachomatis Dir. Specimen TestLJP · Traditional | 04/29/1987SE |
| K864565 | Monabrite Cytomegalovirus (CMV) Ifa KitGQH · Traditional | 02/19/1987SE |
| K864677 | TSH Maiaclone Immunoradiometric Assay Kit/Mag SepJLW · Traditional | 01/07/1987SE |
| K862813 | FSH Maiaclone Immunoradiometric Assay KitCGJ · Traditional | 09/16/1986SE |
| K862262 | HCG Maiaclone Immunoradiometric Kit/Kit ComponentsJHI · Traditional | 07/29/1986SE |
| K861379 | Monabrite Respir Syncytial Virus(Rsv) Test KitLKT · Traditional | 07/16/1986SE |
| K861361 | Estradiol Maia Ria Kit Magnetic Separation PhaseCHP · Traditional | 06/27/1986SE |
| K854615 | Monabrite Chlamydia Trach Culture Confirmation TesLKI · Traditional | 01/28/1986SE |
| K842966 | Renin Radioimmunoassay Test KitCIB · Traditional | 10/11/1984SE |
| K842965 | Gastrin Radioimmunoassay Test Kit · Traditional | 10/11/1984SE |
| K833396 | C-Peptide Radioimmunoassay Test KitJKD · Traditional | 04/13/1984SE |