Cleared Traditional

K833618 - ORTHO ELT-8/DS HEMATOLOGY ANALYZER

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

K833618 · Ortho Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K833618

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.

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 K833618.
AUTOLYZER 800
K841852 · Geometric Data, Div. Smithkline Corp. · Sep 1984
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