Cleared Traditional

K842146 - HISTOPAQUE-1077 (FDA 510(k) Clearance)

Class I Hematology device.

K842146 · Sigma Chemical Co. · Hematology device
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Jul 1984
Decision
58d
Days
Class 1
Risk

K842146 is an FDA 510(k) clearance for the HISTOPAQUE-1077. Classified as Lymphocyte Separation Medium (product code JCF), Class I - General Controls.

Submitted by Sigma Chemical Co. (Walker, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8500 - 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.

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Submission Details

510(k) Number K842146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date July 27, 1984
Days to Decision 58 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 113d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JCF Lymphocyte Separation Medium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8500
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.