IS H. PYLORI IGG ELISA TEST SYSTEM— 510(k) K990462

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K990462 for IS H. PYLORI IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-09-03. Applicant: Columbia Bioscience, Inc..

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1999-02-12
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.