FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
FDA 510(k) clearance K160462 · decided 2016-03-17
Clearance details
- K-number
- K160462
- Device name
- FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-02-19
- Decision date
- 2016-03-17
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- PLO
- Device class
- 2
- Regulation number
- 866.3970
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) | QIAGEN GmbH | 2024-10-29 |
| Simplexa VZV Direct, Simplexa VZV Positive Control Pack (K190219) | Diasorin Molecular, LLC | 2019-05-13 |
| FilmArray Meningitis/Encephalitis(ME) Panel (DEN150013) | Biofire Diagnostics, LLC | 2015-10-08 |
Recalls involving this device
No recalls on record reference this clearance.