IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite 2000 Syphilis Screen Test System.

Pre-market Notification Details

Device IDK091361
510k NumberK091361
Device Name:IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
ClassificationEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 6695 RIVER CREST POINT Suwanee,  GA  30024
ContactCarolyn K George
CorrespondentCarolyn K George
SIEMENS HEALTHCARE DIAGNOSTICS 6695 RIVER CREST POINT Suwanee,  GA  30024
Product CodeLIP  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-08
Decision Date2009-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414976891 K091361 000
00630414976686 K091361 000

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