510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150013Unknown

FilmArray Meningitis/Encephalitis(ME) Panel

BioFire Diagnostics, LLC, Salt Lake City UT / Direct, Unknown
FDA source (opens on fda.gov)

DEN150013 is the FDA 510(k) clearance record for FilmArray Meningitis/Encephalitis(ME) Panel, a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code PLO (Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System). FDA's definition for product code PLO reads: "A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is...". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show no recalls naming DEN150013.

Clearance record

Decision date
Received
(182 days to decision)
Product code
PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Regulation
21 CFR 866.3970
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Diagnostics, LLC 390 Wakara Way, Salt Lake City UT
Third party review
No

Clearances, product code PLO

Trailing 12 months

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

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