Cleared Traditional

COULTER MULTI Q PREP

K935953 · Coulter Corp. · Hematology
Mar 1994
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K935953 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 Corp. (Miami, US). The FDA issued a Cleared decision on March 11, 1994, 88 days after receiving the submission on December 13, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number K935953 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1993
Decision Date March 11, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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