Beckman-Diagnostic Systems Group
Medical device manufacturer in Brea, CA.
11510(k) clearances
0PMA approvals
0recalls
Device types
- DKC Alcohol Control Materials 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- KHP Acid, Lactic, Enzymatic Method 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CIG Diazo Colorimetry, Bilirubin 1
- JFJ Catalytic Methods, Amylase 1
- JJF Analyzer, Chemistry, Micro, For Clinical Use 1
- DJG Enzyme Immunoassay, Opiates 1
- DKZ Enzyme Immunoassay, Amphetamine 1
- LCM Enzyme Immunoassay, Phencyclidine 1
- DFT Igm, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | 12/12/1994SE |
| K944605 | CX Phencyclidine Reagent for Synschron CX SystemLCM · Traditional | 12/07/1994SE |
| K944604 | CX Amphetamines Reagent for Synchron CX SystemsDKZ · Traditional | 12/07/1994SE |
| K944606 | CX Opiate Reagent for Synchron CX SystemsDJG · Traditional | 11/30/1994SE |
| K942676 | Synchron CX3 DeltaJJF · Traditional | 11/02/1994SE |
| K934293 | Beckman Pancreatic Amylase (Pamy) ReagentJFJ · Traditional | 07/06/1994SE |
| K934068 | Beckman Direct Bilirubin ReagentCIG · Traditional | 04/26/1994SE |
| K936184 | Vigil PRX Chemistry ControlJJY · Traditional | 04/15/1994SE |
| K934271 | Beckman Synchron Lactate ReagentKHP · Traditional | 11/09/1993SE |
| K934046 | Beckman Cholesterol ReagentCHH · Traditional | 10/28/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | 10/27/1993SE |