Company ยท US
Columbia Bioscience, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 1999. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSE | Epstein-Barr Virus, Other | 3 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| LSR | Reagent, Borrelia Serological Reagent | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 |
| LYR | Helicobacter Pylori | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 1999 | K991274 | MUMPS IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | LJY |
| Sep 3, 1999 | K990462 | IS H. PYLORI IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | LYR |
| Feb 2, 1999 | K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | JZO |
| Dec 16, 1998 | K983606 | IS BORRELIA BURGDORFERI IGM TEST SYSTEM Columbia Bioscience, Inc. | LSR |
| Dec 16, 1998 | K983605 | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM Columbia Bioscience, Inc. | LSR |
| Dec 7, 1998 | K983553 | ANTI-TG IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | JZO |
| Nov 25, 1998 | K982352 | VCA IGM ELISA TEST SYSTEM Columbia Bioscience, Inc. | LSE |
| Nov 25, 1998 | K982350 | EA-D IGM ELISA TEST SYSTEM Columbia Bioscience, Inc. | LSE |
| Nov 25, 1998 | K982348 | EBNA-1 IGM ELISA TEST SYSTEM Columbia Bioscience, Inc. | LSE |
| Nov 18, 1998 | K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | MOB |
| Nov 18, 1998 | K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | MOB |
| Nov 5, 1996 | K962113 | ANTHOS PHACTS VERSION MICROPLATE READER Columbia Bioscience, Inc. | JJQ |
| Aug 2, 1996 | K961183 | CBI 7520 READER Columbia Bioscience, Inc. | JJQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||