510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173536Substantially Equivalent

T2Candida 1.1 Panel

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

K173536 is the FDA 510(k) clearance record for T2Candida 1.1 Panel, a class II device, cleared for T2biosystems, Inc. on under FDA product code PII (Candida Species Nucleic Acid Detection System). FDA's definition for product code PII reads: "The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive...". FDA records list 6 510(k) clearances for T2biosystems, Inc., from to . As of , FDA records show no recalls naming K173536.

Clearance record

Decision date
Received
(27 days to decision)
Product code
PII Candida Species Nucleic Acid Detection System
Regulation
21 CFR 866.3960
Device class
Class II
Review panel
Microbiology
Applicant
T2biosystems, Inc. 101 Hartwell Ave., Lexington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PII

Trailing 12 months

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

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