Cleared Traditional

K812947 - MONO-POLY RESOLVING MEDIUM

K812947 is an FDA 510(k) clearance for MONO-POLY RESOLVING MEDIUM, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Hematology device with product code JCF cleared through the Traditional 510(k) pathway after a 142-day FDA review.

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

FDA 510(k) Submission Details - K812947

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 113d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

JCF Device Classification - Class 1, General Controls

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.