510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243759Substantially Equivalent

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

BioFire Diagnostics, LLC, Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243759 is the FDA 510(k) clearance record for BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)), a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code PEN (Gram-Negative Bacteria And Associated Resistance Markers). FDA's definition for product code PEN reads: "A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show no recalls naming K243759.

Clearance record

Decision date
Received
(14 days to decision)
Product code
PEN Gram-Negative Bacteria And Associated Resistance Markers
Regulation
21 CFR 866.3365
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Diagnostics, LLC 515 Colorow Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEN

Trailing 12 months
1 clearance under product code PEN in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PEN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260