Company ยท US
Cooper Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1987. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 |
| DFF | Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
| GTP | Exoenzymes, Multiple, Streptococcal | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 1987 | K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO Cooper Biomedical, Inc. | DAD |
| Feb 13, 1987 | K863868 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT Cooper Biomedical, Inc. | DFF |
| Sep 26, 1986 | K863301 | DEMAND TOTAL PROTEIN Cooper Biomedical, Inc. | CEK |
| Jun 27, 1986 | K861926 | WORTHINGTON HDL PRECIPITATING REAGENT SET Cooper Biomedical, Inc. | LBR |
| Nov 5, 1985 | K854130 | DEMAND ETHYL ALCOHOL Cooper Biomedical, Inc. | DIC |
| Oct 16, 1985 | K853949 | DEMAND ACID PHOSPHATASE REAGENT Cooper Biomedical, Inc. | CKB |
| Jun 25, 1985 | K852262 | ASSIST CLINICAL CHEMISTRY ANALYZER Cooper Biomedical, Inc. | JJE |
| Jun 17, 1985 | K851285 | RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI Cooper Biomedical, Inc. | DCF |
| Jun 11, 1985 | K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM Cooper Biomedical, Inc. | CZP |
| Jun 5, 1985 | K851286 | RADIAL IMMUNODIFFUSION PLATES C3 & C4 Cooper Biomedical, Inc. | CZW |
| May 24, 1985 | K851287 | RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN Cooper Biomedical, Inc. | DDG |
| May 24, 1985 | K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI Cooper Biomedical, Inc. | DEB |
| May 23, 1985 | K851283 | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN Cooper Biomedical, Inc. | DDB |
| May 10, 1985 | K851657 | DEMAND MAGNESIUM Cooper Biomedical, Inc. | JGJ |
| Jul 11, 1984 | K842484 | LEAP LE TEST KIT Cooper Biomedical, Inc. | LKJ |
| Jun 7, 1984 | K841726 | DEMAND C02 Cooper Biomedical, Inc. | KHS |
| May 7, 1984 | K841076 | ION SELECTIVE ELECTRODE Cooper Biomedical, Inc. | JJE |
| Apr 5, 1984 | K840822 | LEAP MONO TEST KIT Cooper Biomedical, Inc. | KTN |
| Dec 27, 1983 | K833738 | LEAP STREP TEST KIT Cooper Biomedical, Inc. | GTP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||