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510(k) K212769

Device
DYNEX SmartPLEX MMRV IgG Assay Kit
Applicant
Dynex Technologies, Inc.
510(k) number
K212769
Product code
OPL
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-29
Date received
2021-08-31
Regulation
866.3510
Classification name
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeff Fisher
Address
14340 Sullyfield Cir. Chantilly VA US 20151 20151

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OPL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111072BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPLBio-Rad Laboratories2011-08-23
K091616BIOPLEX 2200 MMRV IGGBio-Rad Laboratories2010-03-29