Cleared Traditional

K792550 - PONCEAU S STAIN SET

K792550 is an FDA 510(k) clearance for PONCEAU S STAIN SET, manufactured by Electrophoresis Corp. of America. The device is a Class 1 Hematology device with product code KQC cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K792550 · Electrophoresis Corp. of America · Hematology device
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Jan 1980
Decision
37d
Days
Class 1
Risk

K792550 is an FDA 510(k) clearance for the PONCEAU S STAIN SET. Classified as Stains, Hematology (product code KQC), Class I - General Controls.

Submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - 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 Electrophoresis Corp. of America devices

FDA 510(k) Submission Details - K792550

510(k) Number K792550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1979
Decision Date January 16, 1980
Days to Decision 37 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
76d faster than avg
Panel avg: 113d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

KQC Device Classification - Class 1, General Controls

Product Code KQC Stains, Hematology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - KQC Stains, Hematology

Devices cleared under the same product code (KQC) and FDA review panel - the closest regulatory comparables to K792550.
GENERAL DIAGNOSTICS COAG-A-MATE XC
K852843 · Warner-Lambert Co. · Aug 1985
RETIC-SET
K843619 · R&D Systems, Inc. · Oct 1984
RETIC-SET
K841848 · R&D Systems, Inc. · May 1984
VOLU-SOL NMB RETICULOCYTE STAIN
K792496 · Volu Sol Medical Industries · Dec 1979
HEMASTAIN FIXATIVE
K760485 · Geometric Data, Div. Smithkline Corp. · Aug 1976
HEMASTAIN PHOSPHATE BUFFER
K760487 · Geometric Data, Div. Smithkline Corp. · Aug 1976