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— 510(k) K151935
Substantially EquivalentAlere San Diego, Incorporated
FDA 510(k) clearance K151935 for 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, Substantially Equivalent on 2015-08-12. Applicant: Alere San Diego, Incorporated.
Clearance details
- Applicant
- Alere San Diego, Incorporated
- Product code
- Code LYR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.