Cleared Traditional

CD4 CYTOSPHERES KIT

K921279 · Coulter Electronics, Inc. · Hematology
Dec 1992
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K921279 is an FDA 510(k) clearance for the CD4 CYTOSPHERES KIT, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on December 29, 1992, 287 days after receiving the submission on March 17, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K921279 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1992
Decision Date December 29, 1992
Days to Decision 287 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