Cleared Traditional

K850239 - SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-

K850239 is an FDA 510(k) clearance for SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTI..., manufactured by Toa Medical Electronics USA, Inc.. The device is a Class 1 Hematology device with product code GIF cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K850239 · Toa Medical Electronics USA, Inc. · Hematology device
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Apr 1985
Decision
69d
Days
Class 1
Risk

K850239 is an FDA 510(k) clearance for the SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Toa Medical Electronics USA, Inc. (Carson, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - 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

FDA 510(k) Submission Details - K850239

510(k) Number K850239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date April 01, 1985
Days to Decision 69 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
44d faster than avg
Panel avg: 113d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

GIF Device Classification - Class 1, General Controls

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GIF Diluent, Blood Cell

All 18
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K850239.
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · Toa Medical Electronics USA, Inc. · Jul 1988
CELL-DYN ISOTONIC DILUENT
K881130 · Abbott Diagnostics · Mar 1988
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · Abbott Diagnostics · Sep 1987
NSI ELT-D DILUTING FLUID 4000ML
K844782 · Nobel Scientific Industries, Inc. · Mar 1985
HAYEM DILUTING FLUID
K842929 · E K Ind., Inc. · Sep 1984
CYANOMETHEMOGLOBIN REAGENT
K841799 · Reagent Laboratory, Inc. · May 1984