510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K170883Substantially Equivalent

FilmArray NGDS Warrior Panel

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

K170883 is the FDA 510(k) clearance record for FilmArray NGDS Warrior Panel, cleared for Biofire Defense, LLC on under FDA product code PRD. FDA records list 10 510(k) clearances for Biofire Defense, LLC, from to . As of , FDA records show 3 recalls naming K170883.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PRD
Review panel
Immunology
Applicant
Biofire Defense, LLC 79 W 4500 S, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRD

Trailing 12 months

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

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