Cleared Traditional

K842636 - TECHNICON H*1 SYSTEM

K842636 is the FDA 510(k) clearance for TECHNICON H*1 SYSTEM by Technicon Instruments Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K842636 · Technicon Instruments Corp. · Hematology device
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Jul 1984
Decision
18d
Days
Class 2
Risk

K842636 is an FDA 510(k) clearance for the TECHNICON H*1 SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Walker, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Technicon Instruments Corp. devices

Submission Details

510(k) Number K842636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1984
Decision Date July 27, 1984
Days to Decision 18 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
95d faster than avg
Panel avg: 113d · This submission: 18d
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 K842636.
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
K852988 · Technicon Instruments Corp. · Jan 1986
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1985
FACS ANALYZER
K840195 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
K833618 · Ortho Diagnostic Systems, Inc. · Jan 1984
COULTER COUNTER MODEL S-PLUS V
K833600 · Coulter Electronics, Inc. · Jan 1984