Cleared Traditional

K760027 - DSP - STAIN PACK (FDA 510(k) Clearance)

Class I Hematology device.

K760027 · Harleco · Hematology device
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Jul 1976
Decision
36d
Days
Class 1
Risk

K760027 is an FDA 510(k) clearance for the DSP - STAIN PACK. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976 after a review of 36 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 Harleco devices

Submission Details

510(k) Number K760027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1976
Decision Date July 20, 1976
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 113d · This submission: 36d
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.