Columbia Bioscience, Inc.
Frederick, MD, US
Columbia Bioscience, Inc. appears in FDA device records in Frederick, MD. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Columbia Bioscience, Inc. between 1996 and 1999. The busiest year on record is 1998, with 8. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1998 | 8 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991274 | MUMPS IGG ELISA TEST SYSTEM | LJY | Substantially Equivalent | |
| K990462 | IS H. PYLORI IGG ELISA TEST SYSTEM | LYR | Substantially Equivalent | |
| K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM | JZO | Substantially Equivalent | |
| K983606 | IS BORRELIA BURGDORFERI IGM TEST SYSTEM | LSR | Substantially Equivalent | |
| K983605 | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | |
| K983553 | ANTI-TG IGG ELISA TEST SYSTEM | JZO | Substantially Equivalent | |
| K982352 | VCA IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K982350 | EA-D IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K982348 | EBNA-1 IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | MOB | Substantially Equivalent | |
| K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM | MOB | Substantially Equivalent | |
| K962113 | ANTHOS PHACTS VERSION MICROPLATE READER | JJQ | Substantially Equivalent | |
| K961183 | CBI 7520 READER | JJQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LSEEpstein-Barr Virus, Other
- LYRHelicobacter Pylori
- LSRReagent, Borrelia Serological Reagent
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain