Cleared Traditional

K833618 - ORTHO ELT-8/DS HEMATOLOGY ANALYZER

K833618 is the FDA 510(k) clearance for ORTHO ELT-8/DS HEMATOLOGY ANALYZER by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K833618 · Ortho Diagnostic Systems, Inc. · Hematology device
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Jan 1984
Decision
91d
Days
Class 2
Risk

K833618 is an FDA 510(k) clearance for the ORTHO ELT-8/DS HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 91 days - within the typical 510(k) review window.

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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K833618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date January 13, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 113d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K833618.
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1985
TECHNICON H*1 SYSTEM
K842636 · Technicon Instruments Corp. · Jul 1984
FACS ANALYZER
K840195 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
COULTER COUNTER MODEL S-PLUS V
K833600 · Coulter Electronics, Inc. · Jan 1984
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
K831271 · Ortho Diagnostic Systems, Inc. · Jul 1983
COULTER-COUNTER #S PLUS IV & LYSE S +D
K823355 · Coulter Electronics, Inc. · Dec 1982