Dade Chemistry Systems, Inc.
Medical device manufacturer in Glasgow, DE.
13510(k) clearances
0PMA approvals
0recalls
Device types
- JIT Calibrator, Secondary 4
- JMG Radioimmunoassay (Two-Site Solid Phase)… 1
- JHY Colorimetric Method, Cpk Or Isoenzymes 1
- JIW Calibrator, Surrogate 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- DHA System, Test, Human Chorionic Gonadotropin 1
- CEC Radioimmunoassay, Free Thyroxine 1
- LTJ Prostate-Specific Antigen (Psa) For… 1
- JJX Single (Specified) Analyte Controls… 1
- MMI Immunoassay Method, Troponin Subunit 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K973650 | Troponin (Trop) MethodMMI · Traditional | 10/20/1997SE |
| K973100 | Prostate Specific Antigen (Psa) CalibratorJIT · Traditional | 09/29/1997SE |
| K973099 | Prostate Specific Antigen ControlJJX · Traditional | 09/29/1997SE |
| K973101 | Prostate Specific Antigen MethodLTJ · Traditional | 09/18/1997SE |
| K971141 | FT4 Method for the Dimension RXL Clinical Chemistry SystemCEC · Traditional | 04/28/1997SE |
| K970387 | Human Chorionic Gonadotropin MethodDHA · Traditional | 03/10/1997SE |
| K970393 | Thyroid Stimulating Hormone MethodJLW · Traditional | 03/03/1997SE |
| K970336 | MMB CalibratorJIT · Traditional | 03/03/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | 02/20/1997SE |
| K970389 | Thyroid CalibratorJIT · Traditional | 02/18/1997SE |
| K970343 | MMB MethodJHY · Traditional | 02/14/1997SE |
| K963498 | Ferr Flex Reagent CartridgeJMG · Traditional | 01/24/1997SE |
| K963493 | Ferritin CalibratorJIT · Traditional | 12/03/1996SE |