DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

Method, Nephelometric, Immunoglobulins (g, A, M)

BECKMAN COULTER INC.

The following data is part of a premarket notification filed by Beckman Coulter Inc. with the FDA for Dxc 700 Au Clinical Chemistry Analyzer, Au Igg Reagent.

Pre-market Notification Details

Device IDK162208
510k NumberK162208
Device Name:DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
ClassificationMethod, Nephelometric, Immunoglobulins (g, A, M)
Applicant BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea,  CA  92821
ContactGeraldine Fuentespina
CorrespondentGeraldine Fuentespina
BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea,  CA  92821
Product CodeCFN  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-05
Decision Date2017-01-09
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.