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FDA 510(k)

DYNEX SmartPLEX MMRV IgG Assay Kit

K-Number: K212769 · 2023-09-29

ApplicantDynex Technologies, Inc.
Decision Date2023-09-29
Product CodeOPL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DYNEX SmartPLEX MMRV IgG Assay Kit is the device name listed in this FDA 510(k) record. The listed applicant is Dynex Technologies, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K212769. The device is classified under product code OPL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNEX SmartPLEX MMRV IgG Assay Kit?

DYNEX SmartPLEX MMRV IgG Assay Kit is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Dynex Technologies, Inc.. The 510(k) number is K212769.

When did DYNEX SmartPLEX MMRV IgG Assay Kit receive FDA 510(k) clearance?

DYNEX SmartPLEX MMRV IgG Assay Kit received FDA 510(k) clearance on 2023-09-29, under 510(k) number K212769.

Who is the listed applicant for DYNEX SmartPLEX MMRV IgG Assay Kit?

The FDA 510(k) record lists Dynex Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNEX SmartPLEX MMRV IgG Assay Kit?

The FDA product code for DYNEX SmartPLEX MMRV IgG Assay Kit is OPL.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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