Cleared Traditional

K883836 - COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II

K883836 is an FDA 510(k) clearance for COULTER CLONE QUICK STAIN WHOLE BLOOD L..., manufactured by Coulter Immunology. The device is a Class 1 Hematology device with product code GGK cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K883836 · Coulter Immunology · Hematology device
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Nov 1988
Decision
79d
Days
Class 1
Risk

K883836 is an FDA 510(k) clearance for the COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8540 - 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 Coulter Immunology devices

FDA 510(k) Submission Details - K883836

510(k) Number K883836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1988
Decision Date November 30, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 113d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

GGK Device Classification - Class 1, General Controls

Product Code GGK Products, Red-cell Lysing Products
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8540
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 - GGK Products, Red-cell Lysing Products

All 16
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K883836.
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
K874054 · Fisher Scientific Co., LLC · Oct 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · Abbott Diagnostics · Sep 1987
PIASTRINIT
K863114 · J. D. Assoc. · Nov 1986
HEMOLYSE
K863503 · Reagent Laboratory, Inc. · Oct 1986
NSI LYSING-D REAGENT -4000 ML
K850944 · Nobel Scientific Industries, Inc. · Mar 1985
ACETIC ACID 1% V/V
K842938 · E K Ind., Inc. · Sep 1984