Atellica IM Total HCG (ThCG)

Visual, Pregnancy Hcg, Prescription Use

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 Total Hcg (thcg).

Pre-market Notification Details

Device IDK172322
510k NumberK172322
Device Name:Atellica IM Total HCG (ThCG)
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactAnoop Joy
CorrespondentAnoop Joy
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-01
Decision Date2018-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414600079 K172322 000
00630414600062 K172322 000
00630414600055 K172322 000
00630414600048 K172322 000
00630414600031 K172322 000
00630414600024 K172322 000
00630414294254 K172322 000

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