Atlas FDA

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

FDA 510(k) clearance K242256 · decided 2024-10-29

Clearance details

K-number
K242256
Device name
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
Applicant
QIAGEN GmbH
Decision
Substantially Equivalent
Date received
2024-07-31
Decision date
2024-10-29
Days to decision
90 days
Clearance type
Traditional
Product code
PLO
Device class
2
Regulation number
866.3970
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hilden, DE
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch QIAGEN GmbH

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Simplexa VZV Direct, Simplexa VZV Positive Control Pack (K190219)Diasorin Molecular, LLC2019-05-13
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (K160462)Biofire Diagnostics, LLC2016-03-17
FilmArray Meningitis/Encephalitis(ME) Panel (DEN150013)Biofire Diagnostics, LLC2015-10-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
therascreen® PIK3CA RGQ PCR Kit (P190001/S002)QIAGEN GmbH2025-10-22
QIAGEN therascreen® FGFR RGQ RT-PCR Kit (P180043/S007)QIAGEN GmbH2025-10-03
therascreen® KRAS RGQ PCR Kit (P110027/S018)QIAGEN GmbH2025-01-16
therascreen FGFR RGQ PCR Kit (P180043/S008)QIAGEN GmbH2024-12-06
therascreen FGFR RGQ RT-PCR Kit (P180043/S009)QIAGEN GmbH2024-10-23
therascreen® KRAS RGQ PCR Kit (P110027/S017)QIAGEN GmbH2024-06-21
therascreen FGFR RGQ RT-PCR Kit (P180043/S006)QIAGEN GmbH2023-12-22
QIAGEN therascreen® KRAS RGQ PCR Kit (P110027/S016)QIAGEN GmbH2023-10-06