LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER— 510(k) K111387
Substantially EquivalentIquum, Inc.
FDA 510(k) clearance K111387 for LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER, Substantially Equivalent on 2011-08-04. Applicant: Iquum, Inc.. Device class: 2.
Clearance details
- Applicant
- Iquum, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code OCC
view allMore clearances from Iquum, Inc.
view allAdverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
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 →
Recalls naming K111387
K-number listed on FDA's recall record- Z-0828-2022 — cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- Z-2203-2016 — cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
- Z-2216-2016 — cobas¿ Liat¿ Analyzer
- Z-2543-2015 — cobas Liat Analyzer, for in vitro diagnostic use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111387.
Data sourced from openFDA. This site is unofficial and independent of the FDA.