N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL2

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 Assay, N Latex Flc Lambda Assay, N Flc Standard Sl, N Flc Control Sl1 & Sl2.

Pre-market Notification Details

Device IDK171742
510k NumberK171742
Device Name:N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL2
ClassificationKappa, Antigen, Antiserum, Control
Applicant Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg,  DE 35041
ContactChristine Perkins
CorrespondentChristine Perkins
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 Received2017-06-12
Decision Date2017-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414237503 K171742 000
00630414237497 K171742 000
00630414237480 K171742 000
00630414237473 K171742 000
00842768031465 K171742 000
00842768031458 K171742 000
00842768031441 K171742 000
00842768031434 K171742 000

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