N Latex FLC Kappa, N Latex FLC Lambda

Kappa, Antigen, Antiserum, Control

Siemens Healthcare Diagnostics Products GmbH

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for N Latex Flc Kappa, N Latex Flc Lambda.

Pre-market Notification Details

Device IDK201496
510k NumberK201496
Device Name:N Latex FLC Kappa, N Latex FLC Lambda
ClassificationKappa, Antigen, Antiserum, Control
Applicant Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str.- 76 Marburg,  DE 35041
ContactChristine Perkins
CorrespondentKerstin Koenigs
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str.- 76 Marburg,  DE 35041
Product CodeDFH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-05
Decision Date2021-10-29

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