Cleared Traditional

K831131 - CASE WRIGHT-GIEMSA STAIN PAK (FDA 510(k) Clearance)

Class I Pathology device.

K831131 · Case Instruments · Pathology device
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Jun 1983
Decision
63d
Days
Class 1
Risk

K831131 is an FDA 510(k) clearance for the CASE WRIGHT-GIEMSA STAIN PAK. Classified as Giemsa Stain (product code HYF), Class I - General Controls.

Submitted by Case Instruments (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 63 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.

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Submission Details

510(k) Number K831131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1983
Decision Date June 08, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 77d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HYF Giemsa 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.