DYNEX SmartPLEX MMRV IgG Assay Kit— 510(k) K212769

Name: FDA 510(k) clearance K212769
Creator: U.S. Food and Drug Administration
Published: 2023-09-29

Substantially Equivalent

Dynex Technologies, Inc.

FDA 510(k) clearance K212769 for DYNEX SmartPLEX MMRV IgG Assay Kit, Substantially Equivalent on 2023-09-29. Applicant: Dynex Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Dynex Technologies, Inc.
Product code: Code OPL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2021-08-31
Decision date: 2023-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

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