Afinion HbA1c Dx On Afinion 2

Hemoglobin A1c Test System

Alere Technologies AS

The following data is part of a premarket notification filed by Alere Technologies As with the FDA for Afinion Hba1c Dx On Afinion 2.

Pre-market Notification Details

Device IDK182988
510k NumberK182988
Device Name:Afinion HbA1c Dx On Afinion 2
ClassificationHemoglobin A1c Test System
Applicant Alere Technologies AS Kjelsaasveien 161 Oslo,  NO No-0884
ContactMonica Vallestad
CorrespondentMonica Vallestad
Alere Technologies AS Kjelsaasveien 161 Oslo,  NO No-0884
Product CodePDJ  
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-29
Decision Date2018-11-29
Summary:summary

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