Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)— 510(k) K143653

Substantially Equivalent

Nanosphere, Inc.

FDA 510(k) clearance K143653 for Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), Substantially Equivalent on 2015-09-04. Applicant: Nanosphere, Inc..

Clearance details

Applicant: Nanosphere, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2014-12-23
Decision date: 2015-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.