Cleared Traditional

COULTER MULTI-Q-PREP

K923530 · Coulter Electronics, Inc. · Hematology
Oct 1992
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K923530 is an FDA 510(k) clearance for the COULTER MULTI-Q-PREP, a Apparatus, Automated Blood Cell Diluting (Class I — General Controls, product code GKH), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on October 14, 1992, 90 days after receiving the submission on July 16, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number K923530 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1992
Decision Date October 14, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKH — Apparatus, Automated Blood Cell Diluting
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.5240

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