Atellica IM Folate Assay

Acid, Folic, Radioimmunoassay

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im Folate Assay.

Pre-market Notification Details

Device IDK172201
510k NumberK172201
Device Name:Atellica IM Folate Assay
ClassificationAcid, Folic, Radioimmunoassay
Applicant Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactDarius Daruwala
CorrespondentDarius Daruwala
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeCGN  
CFR Regulation Number862.1295 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-21
Decision Date2018-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414599007 K172201 000
00630414598994 K172201 000
00630414598987 K172201 000
00630414598970 K172201 000
00630414598963 K172201 000
00630414597690 K172201 000
00630414293653 K172201 000

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