Cleared Traditional

ADVIA 2120i, ADVIA 2120

K162977 · Siemens Healthcare Diagnostics · Hematology
Aug 2017
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K162977 is an FDA 510(k) clearance for the ADVIA 2120i, ADVIA 2120, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Siemens Healthcare Diagnostics (New York, US). The FDA issued a Cleared decision on August 11, 2017, 289 days after receiving the submission on October 26, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K162977 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2016
Decision Date August 11, 2017
Days to Decision 289 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220

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