510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231336Substantially Equivalent

T2 Biothreat Panel

T2biosystems, Inc., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231336 is the FDA 510(k) clearance record for T2 Biothreat Panel, a class II device, cleared for T2biosystems, Inc. on under FDA product code QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents). FDA's definition for product code QVR reads: "A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens". FDA records list 6 510(k) clearances for T2biosystems, Inc., from to . As of , FDA records show no recalls naming K231336.

Clearance record

Decision date
Received
(130 days to decision)
Product code
QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Regulation
21 CFR 866.4000
Device class
Class II
Review panel
Immunology
Applicant
T2biosystems, Inc. 101 Hartwell Ave., Lexington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVR

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