NeuMoDx GBS Assay— 510(k) K173725
Substantially EquivalentNeumodx Molecular, Inc.
FDA 510(k) clearance K173725 for NeuMoDx GBS Assay, Substantially Equivalent on 2018-06-26. Applicant: Neumodx Molecular, Inc..
Clearance details
- Applicant
- Neumodx Molecular, Inc.
- Product code
- Code NJR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.