510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212769Substantially Equivalent

DYNEX SmartPLEX MMRV IgG Assay Kit

Dynex Technologies, Inc., Chantilly VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212769 is the FDA 510(k) clearance record for DYNEX SmartPLEX MMRV IgG Assay Kit, a class II device, cleared for Dynex Technologies, Inc. on under FDA product code OPL (Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus). FDA's definition for product code OPL reads: "The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay...". FDA records list one 510(k) clearance for Dynex Technologies, Inc. As of , FDA records show no recalls naming K212769.

Clearance record

Decision date
Received
(759 days to decision)
Product code
OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Dynex Technologies, Inc. 14340 Sullyfield Cir., Chantilly VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OPL

Trailing 12 months

FDA records hold no clearances under product code OPL in the trailing twelve months.

FDA records show no clearances under product code OPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260