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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Columbia Bioscience, Inc. — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

129 daysmedian FDA review time
158 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991274MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1999-09-031431
K990462IS H. PYLORI IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1999-09-032030
K984228IS ANTI-TPO IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1999-02-02690
K983606IS BORRELIA BURGDORFERI IGM TEST SYSTEMColumbia Bioscience, Inc.1998-12-16630
K983605IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-12-16630
K983553ANTI-TG IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-12-07590
K982350EA-D IGM ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-251420
K982348EBNA-1 IGM ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-251420
K982352VCA IGM ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-251420
K983740IS-ANTI-PR3 IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-18270
K983390IS-ANTI-MPO IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-18540
K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.1996-11-051580
K961183CBI 7520 READERColumbia Bioscience, Inc.1996-08-021290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda