BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

System, Test, Anticardiolipin Immunological

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Apls Igg And Iga Kit And Calibrator And Control Sets.

Pre-market Notification Details

Device IDK103834
510k NumberK103834
Device Name:BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia,  CA  94510
ContactJuang Wang
CorrespondentJuang Wang
Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia,  CA  94510
Product CodeMID  
Subsequent Product CodeJIX
Subsequent Product CodeJJX
Subsequent Product CodeMSV
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-30
Decision Date2012-03-30
Summary:summary

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