IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

System, Test, Radioallergosorbent (rast) Immunological

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite 2000 3gallergy Specific Ige Assay Kit.

Pre-market Notification Details

Device IDK083853
510k NumberK083853
Device Name:IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
ContactClare Santulli
CorrespondentClare Santulli
SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-24
Decision Date2009-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414979212 K083853 000
00630414972800 K083853 000
00630414973777 K083853 000
00630414978888 K083853 000
00630414978901 K083853 000
00630414978932 K083853 000
00630414978963 K083853 000
00630414978987 K083853 000
00630414979069 K083853 000
00630414979205 K083853 000
00630414970691 K083853 000

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