Cooper Biomedical, Inc.
Mchenry, IL, US
Cooper Biomedical, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Cooper Biomedical, Inc. between 1983 and 1987. The busiest year on record is 1985, with 10. The most recent is 1987, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 4 |
| 1985 | 10 |
| 1986 | 2 |
| 1987 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | DAD | Substantially Equivalent | |
| K863868 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | DFF | Substantially Equivalent | |
| K863301 | DEMAND TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K861926 | WORTHINGTON HDL PRECIPITATING REAGENT SET | LBR | Substantially Equivalent | |
| K854130 | DEMAND ETHYL ALCOHOL | DIC | Substantially Equivalent | |
| K853949 | DEMAND ACID PHOSPHATASE REAGENT | CKB | Substantially Equivalent | |
| K852262 | ASSIST CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K851285 | RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI | DCF | Substantially Equivalent | |
| K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM | CZP | Substantially Equivalent | |
| K851286 | RADIAL IMMUNODIFFUSION PLATES C3 & C4 | CZW | Substantially Equivalent | |
| K851287 | RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN | DDG | Substantially Equivalent | |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | DEB | Substantially Equivalent | |
| K851283 | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN | DDB | Substantially Equivalent | |
| K851657 | DEMAND MAGNESIUM | JGJ | Substantially Equivalent | |
| K842484 | LEAP LE TEST KIT | LKJ | Substantially Equivalent | |
| K841726 | DEMAND C02 | KHS | Substantially Equivalent | |
| K841076 | ION SELECTIVE ELECTRODE | JJE | Substantially Equivalent | |
| K840822 | LEAP MONO TEST KIT | KTN | Substantially Equivalent | |
| K833738 | LEAP STREP TEST KIT | GTP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- DCFAlbumin, Antigen, Antiserum, Control
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- DFFAlpha-1-Antichymotrypsin, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LKJAntinuclear Antibody, Antigen, Control
- CEKBiuret (Colorimetric), Total Protein
- DDBCeruloplasmin, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- KHSEnzymatic, Carbon-Dioxide
- GTPExoenzymes, Multiple, Streptococcal
- DADHaptoglobin, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- LBRLdl & Vldl Precipitation, Hdl
- JGJPhotometric Method, Magnesium
- KTNSystem, Test, Infectious Mononucleosis
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain