Cleared Traditional

K842818 - CST

K842818 is an FDA 510(k) clearance for CST, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Hematology device with product code JCF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K842818 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Oct 1984
Decision
97d
Days
Class 1
Risk

K842818 is an FDA 510(k) clearance for the CST. Classified as Lymphocyte Separation Medium (product code JCF), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 97 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K842818

510(k) Number K842818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1984
Decision Date October 23, 1984
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
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.

Regulatory Peers - JCF Lymphocyte Separation Medium

All 8
Devices cleared under the same product code (JCF) and FDA review panel - the closest regulatory comparables to K842818.
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
K874328 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
LEUCOPREP BRAND TUBE
K872775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
LEUCO PREP
K854093 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
HISTOPAQUE-1077
K842146 · Sigma Chemical Co. · Jul 1984
MONO-POLY RESOLVING MEDIUM
K812947 · Flow Laboratories, Inc. · Mar 1982
IMMUNO-CELL IMMUNO-SEP KIT
K812411 · Kallestad Laboratories, Inc. · Nov 1981