510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965141Substantially Equivalent

Truquant Br Ria

Biomira USA, Inc., Cranberry NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965141 is the FDA 510(k) clearance record for TRUQUANT BR RIA, a class II device, cleared for Biomira USA, Inc. on under FDA product code MOI (System, Test, Immunological, Antigen, Tumor). FDA records list one 510(k) clearance for Biomira USA, Inc. As of , FDA records show no recalls naming K965141.

Clearance record

Decision date
Received
(312 days to decision)
Product code
MOI System, Test, Immunological, Antigen, Tumor
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Biomira USA, Inc. 1002 E. Park Blvd., Cranberry NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MOI

Trailing 12 months

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

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