IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

System, Test, Radioallergosorbent (rast) Immunological

Siemens Healthcare Diagnostics Inc.

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

Pre-market Notification Details

Device IDK112523
510k NumberK112523
Device Name:IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactGaro Mimaryan
CorrespondentGaro Mimaryan
Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-31
Decision Date2012-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414988160 K112523 000
00630414988153 K112523 000
00630414988146 K112523 000
00630414988122 K112523 000
00630414982915 K112523 000

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