Genchem, Inc.
Medical device manufacturer in Brea, CA.
8510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K090283 | Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3JIX · Abbreviated | 06/05/2009SE |
| K040977 | Genchem Electrolyte BufferJGS · Traditional | 12/27/2004SE |
| K040976 | Genchem Creatinine ReagentCGX · Traditional | 12/27/2004SE |
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | 12/27/2004SE |
| K040974 | Glucose Oxidase, GlucoseCGA · Traditional | 12/27/2004SE |
| K040973 | Bun ReagentCDS · Traditional | 12/27/2004SE |
| K040972 | Calcium, Azo Dye ReagentCJY · Traditional | 12/27/2004SE |
| K040971 | Genchem Ise Electrolyte ReferenceJGS · Traditional | 12/22/2004SE |