BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

Enzyme Linked Immunoabsorbent Assay, Rubella

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Rubella & Cmv Igm Kit On The Bioplex 2200 Multi Analyte Detection System.

Pre-market Notification Details

Device IDK092587
510k NumberK092587
Device Name:BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant Bio-Rad Laboratories 5500 E. SECOND ST Benicia,  CA  94510
ContactPatricia Klimley
CorrespondentPatricia Klimley
Bio-Rad Laboratories 5500 E. SECOND ST Benicia,  CA  94510
Product CodeLFX  
Subsequent Product CodeJIX
Subsequent Product CodeJJX
Subsequent Product CodeLFZ
Subsequent Product CodeLKQ
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-24
Decision Date2010-12-03
Summary:summary

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