Cleared Traditional

K853241 - HEMATOLOGY STAIN PACK

K853241 is an FDA 510(k) clearance for HEMATOLOGY STAIN PACK, manufactured by Fisher Scientific Co., LLC. The device is a Class 1 Pathology device with product code IAF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K853241 · Fisher Scientific Co., LLC · Pathology device
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Aug 1985
Decision
18d
Days
Class 1
Risk

K853241 is an FDA 510(k) clearance for the HEMATOLOGY STAIN PACK. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Fair Lawn, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 18 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 Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K853241

510(k) Number K853241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date August 19, 1985
Days to Decision 18 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
59d faster than avg
Panel avg: 77d · This submission: 18d
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 K853241.
WRIGHT-GLEMSA STAIN
K890673 · Sigma Diagnostics, Inc. · Feb 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · Sigma Diagnostics, Inc. · Feb 1989
WRIGHT STAIN
K842744 · E K Ind., Inc. · Aug 1984
WRIGHT-GIEMSA QUICK STAIN
K842745 · E K Ind., Inc. · Aug 1984
HEMATOLOGY WRIGHT'S STAIN PACK
K833678 · J.S. Medical Assoc. · Nov 1983
HEMAQUIK II STAINING SOLUTION #55961
K830542 · Accra Laboratories, Inc. · Mar 1983