510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180966Substantially Equivalent

FilmArray Pneumonia Panel

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

K180966 is the FDA 510(k) clearance record for FilmArray Pneumonia Panel, a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code QDP (Respiratory Panel). FDA's definition for product code QDP reads: "The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in...". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show 4 recalls naming K180966.

Clearance record

Decision date
Received
(210 days to decision)
Product code
QDP Respiratory Panel
Regulation
21 CFR 866.3985
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 QDP

Trailing 12 months

FDA records hold no clearances under product code QDP in the trailing twelve months.

FDA records show no clearances under product code QDP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDP, 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 20260
October 20260