Cleared Traditional

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I

K102644 · Siemens Healthcare Diagnostics · Hematology
Nov 2011
Decision
435d
Days
Class 2
Risk

About This 510(k) Submission

K102644 is an FDA 510(k) clearance for the ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I, 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 November 23, 2011, 435 days after receiving the submission on September 14, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K102644 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2010
Decision Date November 23, 2011
Days to Decision 435 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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