Cooper Biomedical, Inc.
Medical device manufacturer in Malvern, PA.
19510(k) clearances
0PMA approvals
0recalls
Device types
- JJE Analyzer, Chemistry (Photometric… 2
- CZW Complement C3, Antigen, Antiserum, Control 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- DFF Alpha-1-Antichymotrypsin, Antigen… 1
- CEK Biuret (Colorimetric), Total Protein 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- DIC Alcohol Dehydrogenase, Specific Reagent For… 1
- CKB Acid Phosphatase, Naphthyl Phosphate 1
- DCF Albumin, Antigen, Antiserum, Control 1
- CZP Iga, Antigen, Antiserum, Control 1
- GTP Exoenzymes, Multiple, Streptococcal 1
- DDG Transferrin, Antigen, Antiserum, Control 1
- DEB Alpha-2-Macroglobulin, Antigen, Antiserum… 1
- DDB Ceruloplasmin, Antigen, Antiserum, Control 1
- JGJ Photometric Method, Magnesium 1
- LKJ Antinuclear Antibody, Antigen, Control 1
- KHS Enzymatic, Carbon-Dioxide 1
- KTN System, Test, Infectious Mononucleosis 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | 02/13/1987SE |
| K863868 | Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 AntDFF · Traditional | 02/13/1987SE |
| K863301 | Demand Total ProteinCEK · Traditional | 09/26/1986SE |
| K861926 | Worthington HDL Precipitating Reagent SetLBR · Traditional | 06/27/1986SE |
| K854130 | Demand Ethyl AlcoholDIC · Traditional | 11/05/1985SE |
| K853949 | Demand Acid Phosphatase ReagentCKB · Traditional | 10/16/1985SE |
| K852262 | Assist Clinical Chemistry AnalyzerJJE · Traditional | 06/25/1985SE |
| K851285 | Radial Immunodiffusion Plates CSF Igg & CSF AlbumiDCF · Traditional | 06/17/1985SE |
| K851284 | Radial Immuno-Diffusion Plates Iga, Igd, Igg & IgmCZP · Traditional | 06/11/1985SE |
| K851286 | Radial Immunodiffusion Plates C3 & C4CZW · Traditional | 06/05/1985SE |
| K851287 | Radial Immunodiffusion Plates TransferrinDDG · Traditional | 05/24/1985SE |
| K851282 | Radial Immunodiffusion Plates ALPHA-2 MacroglobuliDEB · Traditional | 05/24/1985SE |
| K851283 | Radial Immunodiffusion Plates-CeruloplasminDDB · Traditional | 05/23/1985SE |
| K851657 | Demand MagnesiumJGJ · Traditional | 05/10/1985SE |
| K842484 | Leap Le Test KitLKJ · Traditional | 07/11/1984SE |
| K841726 | Demand C02KHS · Traditional | 06/07/1984SE |
| K841076 | Ion Selective ElectrodeJJE · Traditional | 05/07/1984SE |
| K840822 | Leap Mono Test KitKTN · Traditional | 04/05/1984SE |
| K833738 | Leap Strep Test KitGTP · Traditional | 12/27/1983SE |