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510(k) K163633

cobas HbA1c Test, cobas b 101 system by Roche Diagnostics Operations — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2017
Date Received
December 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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