Cleared Traditional

K820437 - AVES WRIGHT STAIN

K820437 is an FDA 510(k) clearance for AVES WRIGHT STAIN, manufactured by Helena Laboratories. The device is a Class 1 Pathology device with product code IAF cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K820437 · Helena Laboratories · Pathology device
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Mar 1982
Decision
37d
Days
Class 1
Risk

K820437 is an FDA 510(k) clearance for the AVES WRIGHT STAIN. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 Helena Laboratories devices

FDA 510(k) Submission Details - K820437

510(k) Number K820437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1982
Decision Date March 26, 1982
Days to Decision 37 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 77d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

IAF Device Classification - Class 1, General Controls

Product Code IAF Wright's Stain
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 - IAF Wright's Stain

All 18
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K820437.
MIDAS 1000 WRIGHT STAIN #66010
K822980 · Emd Chemicals, Inc. · Oct 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K822981 · Emd Chemicals, Inc. · Oct 1982
HEMACOUNT WRIGHTS STAIN PACK II #55952
K821457 · Accra Laboratories, Inc. · Jun 1982
ACCRA LAB HEMOTOLOGY
K812848 · Accra Laboratories, Inc. · Oct 1981
ACCRA LAB WRIGHT STAIN
K812504 · Accra Laboratories, Inc. · Sep 1981
HEMAQUIK
K811400 · Accra Laboratories, Inc. · Jun 1981