Cleared Traditional

MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM

K051693 · Bayer Healthcare, LLC · Hematology
Dec 2005
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K051693 is an FDA 510(k) clearance for the MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on December 7, 2005, 167 days after receiving the submission on June 23, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K051693 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2005
Decision Date December 07, 2005
Days to Decision 167 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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