Cleared Traditional

FLOW-COUNT COULTER FLUOROSPHERES

K954688 · Coulter Corp. · Hematology
Feb 1996
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K954688 is an FDA 510(k) clearance for the FLOW-COUNT COULTER FLUOROSPHERES, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on February 29, 1996, 141 days after receiving the submission on October 11, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K954688 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1995
Decision Date February 29, 1996
Days to Decision 141 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