Cleared Traditional

K810684 - HEMOCOLOR STAIN SET (FDA 510(k) Clearance)

Class I Microbiology device.

K810684 · Harleco · Microbiology device
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Apr 1981
Decision
26d
Days
Class 1
Risk

K810684 is an FDA 510(k) clearance for the HEMOCOLOR STAIN SET. Classified as Eosin B (product code ICC), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.1850 - the FDA microbiology 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 K810684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1981
Decision Date April 08, 1981
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ICC Eosin B
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.