Cleared Traditional

K880544 - WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY (FDA 510(k) Clearance)

Class I Hematology device.

K880544 · Wescor, Inc. · Hematology device
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Apr 1988
Decision
52d
Days
Class 1
Risk

K880544 is an FDA 510(k) clearance for the WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY. Classified as Romanowsky Stains (product code GJL), Class I - General Controls.

Submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on April 1, 1988 after a review of 52 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 Wescor, Inc. devices

Submission Details

510(k) Number K880544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date April 01, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 113d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GJL Romanowsky Stains
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.