510(k) K242256
- Device
- QIAstat-Dx Meningitis/Encephalitis (ME) Panel
- Applicant
- QIAGEN GmbH
- 510(k) number
- K242256
- Product code
- PLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-29
- Date received
- 2024-07-31
- Regulation
- 866.3970
- Classification name
- Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Autumn Collasius
- Address
- Qiagen Strasse 1 Hilden DE 40724 40724
FDA Registration Numbers#
- 3014553740
- 3010749841
- 3002773840
- 2023365
- 3004013603
Source Documents#
Other 510(k) Records For Product Code PLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC | 2019-05-13 |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016-03-17 |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | Biofire Diagnostics, LLC | 2015-10-08 |