Cleared Special

ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD

K022331 · Bayer Diagnostics Corp. · Hematology
Sep 2002
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K022331 is an FDA 510(k) clearance for the ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 11, 2002, 55 days after receiving the submission on July 18, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K022331 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2002
Decision Date September 11, 2002
Days to Decision 55 days
Submission Type Special
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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