Cleared Traditional

K852138 - WESCOR STAIN PACK FOR MODEL 7100 AEROSP...

K852138 is the FDA 510(k) clearance for WESCOR STAIN PACK FOR MODEL 7100 AEROSP... by Canyon Diagnostics, Inc.. It is a Class 1 Pathology device (product code IAF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K852138 · Canyon Diagnostics, Inc. · Pathology device
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Jun 1985
Decision
28d
Days
Class 1
Risk

K852138 is an FDA 510(k) clearance for the WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 28 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 Canyon Diagnostics, Inc. devices

Submission Details

510(k) Number K852138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1985
Decision Date June 13, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 77d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 12
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K852138.
WRIGHT-GLEMSA STAIN
K890673 · Sigma Diagnostics, Inc. · Feb 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · Sigma Diagnostics, Inc. · Feb 1989
HEMATOLOGY STAIN PACK
K853241 · Fisher Scientific Co., LLC · Aug 1985
WRIGHT STAIN
K842744 · E K Ind., Inc. · Aug 1984
WRIGHT-GIEMSA QUICK STAIN
K842745 · E K Ind., Inc. · Aug 1984
MIDAS 1000 WRIGHT STAIN #66010
K822980 · Emd Chemicals, Inc. · Oct 1982