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Columbia Bioscience, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K991274MUMPS IGG ELISA TEST SYSTEMSeptember 3, 1999
K990462IS H. PYLORI IGG ELISA TEST SYSTEMSeptember 3, 1999
K984228IS ANTI-TPO IGG ELISA TEST SYSTEMFebruary 2, 1999
K983605IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMDecember 16, 1998
K983606IS BORRELIA BURGDORFERI IGM TEST SYSTEMDecember 16, 1998
K983553ANTI-TG IGG ELISA TEST SYSTEMDecember 7, 1998
K982352VCA IGM ELISA TEST SYSTEMNovember 25, 1998
K982350EA-D IGM ELISA TEST SYSTEMNovember 25, 1998
K982348EBNA-1 IGM ELISA TEST SYSTEMNovember 25, 1998
K983740IS-ANTI-PR3 IGG ELISA TEST SYSTEMNovember 18, 1998
K983390IS-ANTI-MPO IGG ELISA TEST SYSTEMNovember 18, 1998
K962113ANTHOS PHACTS VERSION MICROPLATE READERNovember 5, 1996
K961183CBI 7520 READERAugust 2, 1996