Cleared Traditional

K852988 - TECHNICON H*1 SYSTEM SUB-CLASSIFICATION...

K852988 is the FDA 510(k) clearance for TECHNICON H*1 SYSTEM SUB-CLASSIFICATION... by Technicon Instruments Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K852988 · Technicon Instruments Corp. · Hematology device
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Jan 1986
Decision
190d
Days
Class 2
Risk

K852988 is an FDA 510(k) clearance for the TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 190 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K852988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date January 21, 1986
Days to Decision 190 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
77d slower than avg
Panel avg: 113d · This submission: 190d
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 K852988.
COULTER COUNTER MODEL S-PLUS STKR
K871837 · Coulter Electronics, Inc. · Jul 1987
TECHNICON H*1 SYSTEM (MPXI)
K853027 · Technicon Instruments Corp. · Feb 1986
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · 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
TECHNICON H*1 SYSTEM
K842636 · Technicon Instruments Corp. · Jul 1984