Cleared Traditional

COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS

K961278 · Coulter Corp. · Hematology
Jul 1996
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K961278 is an FDA 510(k) clearance for the COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on July 22, 1996, 110 days after receiving the submission on April 3, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K961278 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1996
Decision Date July 22, 1996
Days to Decision 110 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