510(k) K091616

Device: BIOPLEX 2200 MMRV IGG
Applicant: Bio-Rad Laboratories
510(k) number: K091616
Product code: OPL
Decision: Substantially Equivalent (SESE)
Decision date: 2010-03-29
Date received: 2009-06-03
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#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K212769	DYNEX SmartPLEX MMRV IgG Assay Kit	Dynex Technologies, Inc.	2023-09-29
K111072	BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL	Bio-Rad Laboratories	2011-08-23

summary

Decision Summary