510(k) K160462
- Device
- FilmArray Meningitis/Encephalitis (ME) Panel For Use With FilmArray Torch
- Applicant
- BIOFIRE DIAGNOSTICS, LLC
- 510(k) number
- K160462
- Product code
- PLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-17
- Date received
- 2016-02-19
- Regulation
- 866.3970
- Classification name
- Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
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#
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 |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | Biofire Diagnostics, LLC | 2015-10-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary