510(k) DEN150013
- Device
- FilmArray Meningitis/Encephalitis(ME) Panel
- Applicant
- Biofire Diagnostics, LLC
- 510(k) number
- DEN150013
- Product code
- PLO
- Decision
- Unknown (DENG)
- Decision date
- 2015-10-08
- Date received
- 2015-04-09
- Regulation
- 866.3970
- Classification name
- Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kristen J Kanack
- Address
- 390 Wakara Way Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 2023365
- 3010749841
- 3014553740
- 3004013603
- 3002773840
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | QIAGEN GmbH | 2024-10-29 |
| 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 |