Cleared Traditional

ONYX

K943967 · Coulter Corp. · Hematology
Mar 1995
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K943967 is an FDA 510(k) clearance for the ONYX, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on March 6, 1995, 203 days after receiving the submission on August 15, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K943967 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1994
Decision Date March 06, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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