Cleared Traditional

COULTER STKS

K885093 · Coulter Electronics, Inc. · Hematology
Dec 1988
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K885093 is an FDA 510(k) clearance for the COULTER STKS, 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 28, 1988, 19 days after receiving the submission on December 9, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K885093 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1988
Decision Date December 28, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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