MagXtract Collection Tube— 510(k) K212113

Name: FDA 510(k) clearance K212113
Creator: U.S. Food and Drug Administration
Published: 2022-07-28

Substantially Equivalent

Magbio Genomics, Inc.

FDA 510(k) clearance K212113 for MagXtract Collection Tube, Substantially Equivalent on 2022-07-28. Applicant: Magbio Genomics, Inc.. Device class: 2.

Clearance details

Applicant: Magbio Genomics, Inc.
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2021-07-07
Decision date: 2022-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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