Cleared Traditional

CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER

K890491 · Abbott Diagnostics · Hematology
Apr 1989
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K890491 is an FDA 510(k) clearance for the CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on April 18, 1989, 77 days after receiving the submission on January 31, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K890491 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1989
Decision Date April 18, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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