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.

Clearance details

Applicant: Diagenode
Product code: Code NJR
Advisory panel: Microbiology
Date received: 2018-05-01
Decision date: 2018-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seraing, BE

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