Cobas HbA1c Test, Cobas B 101 System

Assay, Glycosylated Hemoglobin

Roche Diagnostics Operations

The following data is part of a premarket notification filed by Roche Diagnostics Operations with the FDA for Cobas Hba1c Test, Cobas B 101 System.

Pre-market Notification Details

Device IDK163633
510k NumberK163633
Device Name:Cobas HbA1c Test, Cobas B 101 System
ClassificationAssay, Glycosylated Hemoglobin
Applicant Roche Diagnostics Operations 9115 Hague Road Indianapolis,  IN  46250
ContactPatty Bates
CorrespondentPatty Bates
Roche Diagnostics Operations 9115 Hague Road Indianapolis,  IN  46250
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-22
Decision Date2017-07-28
Summary:summary

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