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510(k) K231336

T2 Biothreat Panel by T2biosystems, Inc. — Product Code QVR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
May 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiplex Nucleic Acid Detection System For Biothreat Agents
Device Class
Class II
Regulation Number
866.4000
Review Panel
MI
Submission Type

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

Other clearances by T2biosystems, Inc.

  • K234063 — T2Candida 1.1 Panel (September 13, 2024)
  • K233184 — T2Bacteria® Panel (February 8, 2024)
  • K172708 — T2Bacteria Panel (May 24, 2018)
  • K173536 — T2Candida 1.1 Panel (December 12, 2017)
  • DEN140019 — T2CANDIDA AND T2DX INSTRUMENT (September 22, 2014)

Other clearances for product code QVR

  • K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the (March 22, 2023)