Medical Device Manufacturer · US , Frederick , MD

Columbia Bioscience, Inc.

13 submissions · 13 cleared · Since 1996
13
Total
13
Cleared
0
Denied

Columbia Bioscience, Inc. — FDA 510(k) Submissions

Columbia Bioscience, Inc. has submitted 13 FDA 510(k) premarket notifications since 1996, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Epstein-barr Virus, Other, Test System, Antineutrophil Cytoplasmic Antibodies (anca), System, Test, Thyroid Autoantibody, Reagent, Borrelia Serological Reagent, Colorimeter, Photometer, Spectrophotometer For Clinical Use . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · LYR Helicobacter Pylori · Microbiology
Sep 1999 203d
MUMPS IGG ELISA TEST SYSTEM
K991274 · LJY Enzyme Linked... · Microbiology
Sep 1999 143d
IS ANTI-TPO IGG ELISA TEST SYSTEM
K984228 · JZO System, Test, Thyroid... · Immunology
Feb 1999 69d
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K983605 · LSR Reagent, Borrelia... · Microbiology
Dec 1998 63d
IS BORRELIA BURGDORFERI IGM TEST SYSTEM
K983606 · LSR Reagent, Borrelia... · Microbiology
Dec 1998 63d
ANTI-TG IGG ELISA TEST SYSTEM
K983553 · JZO System, Test, Thyroid... · Immunology
Dec 1998 59d
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · LSE Epstein-barr Virus, Other · Microbiology
Nov 1998 142d
EA-D IGM ELISA TEST SYSTEM
K982350 · LSE Epstein-barr Virus, Other · Microbiology
Nov 1998 142d
VCA IGM ELISA TEST SYSTEM
K982352 · LSE Epstein-barr Virus, Other · Microbiology
Nov 1998 142d
IS-ANTI-MPO IGG ELISA TEST SYSTEM
K983390 · MOB Test System,... · Immunology
Nov 1998 54d
IS-ANTI-PR3 IGG ELISA TEST SYSTEM
K983740 · MOB Test System,... · Immunology
Nov 1998 27d
ANTHOS PHACTS VERSION MICROPLATE READER
K962113 · JJQ Colorimeter, Photometer,... · Chemistry
Nov 1996 158d
CBI 7520 READER
K961183 · JJQ Colorimeter, Photometer,... · Chemistry
Aug 1996 129d
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