Cleared Traditional

K873734 - SYSMEX F-800 15 PARAMETER

K873734 is the FDA 510(k) clearance for SYSMEX F-800 15 PARAMETER by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K873734 · Toa Medical Electronics USA, Inc. · Hematology device
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Nov 1987
Decision
71d
Days
Class 2
Risk

K873734 is an FDA 510(k) clearance for the SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 71 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 Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K873734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date November 25, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 113d · This submission: 71d
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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K873734.
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
K874763 · Instrumentation Laboratory CO · Feb 1988
QBC BLOOD BANK SYSTEM
K874147 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
QBC SYSTEM HEMOGLOBIN
K874427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
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