Cleared Traditional

ABBOTT CELL-DYN 4000 SYSTEM

K961439 · Abbott Diagnostics · Hematology
Oct 1996
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K961439 is an FDA 510(k) clearance for the ABBOTT CELL-DYN 4000 SYSTEM, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Abbott Diagnostics (Santa Clara, US). The FDA issued a Cleared decision on October 18, 1996, 186 days after receiving the submission on April 15, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K961439 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1996
Decision Date October 18, 1996
Days to Decision 186 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