Dimension Hemoglobin A1c Assay

Hemoglobin A1c Test System

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Hemoglobin A1c Assay.

Pre-market Notification Details

Device IDK173909
510k NumberK173909
Device Name:Dimension Hemoglobin A1c Assay
ClassificationHemoglobin A1c Test System
Applicant Siemens Healthcare Diagnostics Inc. P.O. Box 6101 M/S 514 Newark,  DE  19714 -6101
ContactAlan Haley
CorrespondentAlan Haley
Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE Newark,  DE  19702
Product CodePDJ  
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-22
Decision Date2018-07-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414006659 K173909 000
00630414006666 K173909 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.