QIAstat-Dx Meningitis/Encephalitis (ME) Panel— 510(k) K242256
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K242256 for QIAstat-Dx Meningitis/Encephalitis (ME) Panel, Substantially Equivalent on 2024-10-29. Applicant: QIAGEN GmbH. Device class: 2.
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Code PLO
- Device class
- Class 2
- Regulation
- 21 CFR 866.3970
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilden, DE
Recent devices under product code PLO
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 PLO
product code PLO- Death
- 5
- Total
- 5
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.