K243759
- 510(k) number
- K243759
- Device name
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- Applicant
- Biofire Diagnostics, LLC UT · US
- Product code
- PEN — Gram-Negative Bacteria And Associated Resistance Mar
- Decision date
- 2024-12-20
- Date received
- 2024-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243759.pdf
Official FDA record: K243759
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.