510(k) K143171
K143171 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0". The FDA issued a decision of Substantially Equivalent on January 30, 2015. The device falls under product code PEN (Gram-Negative Bacteria And Associated Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2015
- Date Received
- November 4, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gram-Negative Bacteria And Associated Resistance Markers
- Device Class
- Class II
- Regulation Number
- 866.3365
- Review Panel
- MI
- Submission Type
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.