Cleared Traditional

K840054 - PAPANICOLAOU STAIN SYS HT40 (FDA 510(k) Clearance)

Class I Hematology device.

K840054 · Sigma Chemical Co. · Hematology device
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Feb 1984
Decision
42d
Days
Class 1
Risk

K840054 is an FDA 510(k) clearance for the PAPANICOLAOU STAIN SYS HT40. Classified as Stain, Papanicolau (product code HZJ), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 42 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K840054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date February 17, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HZJ Stain, Papanicolau
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.