510(k) K243759
K243759 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))". The FDA issued a decision of Substantially Equivalent on December 20, 2024. 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
- December 20, 2024
- Date Received
- December 6, 2024
- Clearance Type
- Special
- 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.