cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System— 510(k) K153544

Substantially Equivalent

Iquum, Inc.

FDA 510(k) clearance K153544 for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System, Substantially Equivalent on 2016-07-25. Applicant: Iquum, Inc..

Clearance details

Applicant: Iquum, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2015-12-11
Decision date: 2016-07-25
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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.