Cleared Traditional

ADVIA 120 HEMATOLOGY

K003796 · Bayer Corp. · Hematology
Feb 2001
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K003796 is an FDA 510(k) clearance for the ADVIA 120 HEMATOLOGY, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on February 5, 2001, 59 days after receiving the submission on December 8, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K003796 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2000
Decision Date February 05, 2001
Days to Decision 59 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