Alere Signify H. pylori Whole Blood, Serum, Plasma +3 more— 510(k) K151935

Name: FDA 510(k) clearance K151935
Creator: U.S. Food and Drug Administration
Published: 2015-08-12

Substantially Equivalent

Alere San Diego, Incorporated

FDA 510(k) clearance K151935 for Alere Signify H. pylori Whole Blood, Serum, Plasma +3 more, Substantially Equivalent on 2015-08-12. Applicant: Alere San Diego, Incorporated. Device class: 1.

Clearance details

Device name as filed: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only
Applicant: Alere San Diego, Incorporated
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2015-07-14
Decision date: 2015-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.