IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

System, Test, Radioallergosorbent (rast) Immunological

SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Immulite 2000 3gallergy Specific Ige Assay Kit, Model L2kun6.

Pre-market Notification Details

Device IDK091984
510k NumberK091984
Device Name:IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. Los Angeles,  CA  90045 -6900
ContactClare Santulli
CorrespondentClare Santulli
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. Los Angeles,  CA  90045 -6900
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-02
Decision Date2009-10-28
Summary:summary

NIH GUDID Devices

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00630414959887 K091984 000

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