ROTOR-GENE Q MDX— 510(k) K113319
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K113319 for ROTOR-GENE Q MDX, Substantially Equivalent on 2012-02-06. Applicant: QIAGEN GmbH. Device class: 2.
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Code OOI
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
Recent devices under product code OOI
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 OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
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 K113319
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113319.
Data sourced from openFDA. This site is unofficial and independent of the FDA.