DYNEX SmartPLEX MMRV IgG Assay Kit
K号: K212769 · 2023-09-29
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决定日期2023-09-29
产品代码OPL
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器械摘要
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.
常见问题
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.
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