Cleared Traditional

K911626 - SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER

K911626 is an FDA 510(k) clearance for SYSTEM 9000, manufactured by Serono Baker Diagnostics System. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K911626 · Serono Baker Diagnostics System · Hematology device
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Sep 1991
Decision
155d
Days
Class 2
Risk

K911626 is an FDA 510(k) clearance for the SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Serono Baker Diagnostics System (Allentown, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 155 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Serono Baker Diagnostics System devices

FDA 510(k) Submission Details - K911626

510(k) Number K911626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date September 13, 1991
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K911626.
MONOCLONAL ANTIBODY ANTI-CD5
K901188 · Sigma Chemical Co. · Oct 1991
MONOCLONAL ANTIBODY ANTI-CD3
K901189 · Sigma Chemical Co. · Oct 1991
NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
K913259 · Nova Biomedical Corp. · Oct 1991
COULTER(R) MH010
K911385 · Coulter Electronics, Inc. · Jun 1991
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
K904253 · Ortho Diagnostic Systems, Inc. · May 1991
QBC AUTOREADER
K910834 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991