Cleared Traditional

K953598 - SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS

K953598 is an FDA 510(k) clearance for SERIES 9100 PLUS AUTOMATED DIFFERENTIAL..., manufactured by Serono Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K953598 · Serono Diagnostics, Inc. · Hematology device
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Mar 1996
Decision
223d
Days
Class 2
Risk

K953598 is an FDA 510(k) clearance for the SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on March 11, 1996 after a review of 223 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 Diagnostics, Inc. devices

FDA 510(k) Submission Details - K953598

510(k) Number K953598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date March 11, 1996
Days to Decision 223 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 113d · This submission: 223d
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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K953598.
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
K954570 · Ortho Diagnostic Systems, Inc. · Apr 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · Dako Corp. · Mar 1996
HEMATIL 18 (H-18)
K953643 · Texas Intl. Laboratories, Inc. · Mar 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · Coulter Corp. · Feb 1996
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K946055 · Becton Dickinson Immunocytometry Systems · Feb 1996
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
K950342 · Becton Dickinson Immunocytometry Systems · Feb 1996