Bioclinical Systems, Inc.
Medical device manufacturer in Annapolis Junction, MD.
13510(k) clearances
0PMA approvals
0recalls
Device types
- JTY Culture Media, For Isolation Of Pathogenic… 3
- CEP Radioimmunoassay, Luteinizing Hormone 2
- CEJ Tetraphenyl Borate, Colorimetry, Potassium 1
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 1
- CGA Glucose Oxidase, Glucose 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- KLS Enzyme Immunoassay, Theophylline 1
- JXA Kit, Screening, Urine 1
- JTZ Culture Media, Antimicrobial Susceptibility… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | 06/30/1995SE |
| K945911 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsJTZ · Traditional | 04/04/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | 02/03/1994SE |
| K873086 | Round 1JXA · Traditional | 08/24/1987SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | 04/21/1986SE |
| K860333 | Micro-Elisa HLH Test Kit MonoclonalCEP · Traditional | 04/21/1986SE |
| K855227 | Micro-Eia Theophylline Test Kit MonoclonalKLS · Traditional | 04/11/1986SE |
| K854059 | Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit NoJHI · Traditional | 01/13/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | 01/07/1986SE |
| K850257 | BCS Glucose Colorimetric TestCGA · Traditional | 03/05/1985SE |
| K850079 | Now Home Pregn. Test Kit Enzyme Immunoassay HCGLCX · Traditional | 03/05/1985SE |
| K850258 | BCS Potassium Turbidimetric TestCEJ · Traditional | 02/07/1985SE |