Cleared Traditional

K812947 - MONO-POLY RESOLVING MEDIUM (FDA 510(k) Clearance)

Class I Hematology device.

K812947 · Flow Laboratories, Inc. · Hematology device
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Mar 1982
Decision
142d
Days
Class 1
Risk

K812947 is an FDA 510(k) clearance for the MONO-POLY RESOLVING MEDIUM. Classified as Lymphocyte Separation Medium (product code JCF), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1982 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Flow Laboratories, Inc. devices

Submission Details

510(k) Number K812947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1981
Decision Date March 11, 1982
Days to Decision 142 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 113d · This submission: 142d
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.