Cleared Traditional

IMAGN(TM) 2000 SYSTEM

K945756 · Buckman Co., Inc. · Hematology
Dec 1995
Decision
391d
Days
Class 2
Risk

About This 510(k) Submission

K945756 is an FDA 510(k) clearance for the IMAGN(TM) 2000 SYSTEM, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on December 19, 1995, 391 days after receiving the submission on November 23, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K945756 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1994
Decision Date December 19, 1995
Days to Decision 391 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