Cleared Traditional

K923530 - COULTER MULTI-Q-PREP

K923530 is an FDA 510(k) clearance for COULTER MULTI-Q-PREP, manufactured by Coulter Electronics, Inc.. The device is a Class 1 Hematology device with product code GKH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K923530 is an FDA 510(k) clearance for the COULTER MULTI-Q-PREP. Classified as Apparatus, Automated Blood Cell Diluting (product code GKH), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on October 14, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5240 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K923530

510(k) Number K923530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

GKH Device Classification - Class 1, General Controls

Product Code GKH Apparatus, Automated Blood Cell Diluting
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GKH Apparatus, Automated Blood Cell Diluting

All 9
Devices cleared under the same product code (GKH) and FDA review panel - the closest regulatory comparables to K923530.
COULTER CELLPREP
K021150 · Beckman Coulter, Inc. · Jun 2002
COULTER MULTI Q PREP
K935953 · Coulter Corp. · Mar 1994
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
K882767 · Toa Medical Electronics USA, Inc. · Jul 1988
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · Abbott Diagnostics · Jul 1985
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · R&D Systems, Inc. · Oct 1984