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 IDK083314
510k NumberK083314
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 Received2008-11-10
Decision Date2009-03-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414995878 K083314 000
00630414979199 K083314 000
00630414979021 K083314 000
00630414978956 K083314 000
00630414978925 K083314 000
00630414973371 K083314 000

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