Cleared Traditional

COULTERCLONE

K911793 · Coulter Immunology · Hematology
Jul 1991
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K911793 is an FDA 510(k) clearance for the COULTERCLONE, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on July 9, 1991, 78 days after receiving the submission on April 22, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K911793 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1991
Decision Date July 09, 1991
Days to Decision 78 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