Cleared Traditional

E-Z PREP

K831558 · Coulter Electronics, Inc. · Hematology
Jun 1983
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K831558 is an FDA 510(k) clearance for the E-Z PREP, a Spinner, Slide, Automated (Class I — General Controls, product code GKJ), submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 31 days after receiving the submission on May 16, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5850.

Submission Details

510(k) Number K831558 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1983
Decision Date June 16, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKJ — Spinner, Slide, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.5850