ARTUS INFL A/B RG RT-PCR KIT— 510(k) K113323
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K113323 for ARTUS INFL A/B RG RT-PCR KIT, Substantially Equivalent on 2012-02-06. Applicant: QIAGEN GmbH. Device class: 2.
Clearance details
- Applicant
- QIAGEN GmbH
- 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
- Gaithersburg, MD, US
Recent devices under product code OCC
view allMore clearances from QIAGEN GmbH
view all- K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
- K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250324 — QIAstat-Dx GI Panel 2 Mini B
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.