Panther Fusion GBS Assay— 510(k) K181156

Substantially Equivalent

Diagenode

FDA 510(k) clearance K181156 for Panther Fusion GBS Assay, Substantially Equivalent on 2018-07-27. Applicant: Diagenode. Device class: 1.

Clearance details

Applicant: Diagenode
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2018-05-01
Decision date: 2018-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seraing, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NJR

K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems2023-09-27
K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System2022-05-09
K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack2018-11-07
K173725 — NeuMoDx GBS Assay2018-06-26
K173250 — Solana GBS Assay2017-12-21

Recalls naming K181156

K-number listed on FDA's recall record

Z-0907-2025 — Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.Class II·Ongoing·Hologic, Inc.·20241213
Z-0877-2022 — Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.Class II·Ongoing·Hologic, Inc·20220318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181156.

Data sourced from openFDA. This site is unofficial and independent of the FDA.