Cleared Traditional

K834116 - DEAE-DEXTRAN IN PBS

K834116 is an FDA 510(k) clearance for DEAE-DEXTRAN IN PBS, manufactured by Bartels Immunodiagnostic Supplies, Inc.. The device is a Class 1 Microbiology device with product code KIT cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K834116 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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Apr 1984
Decision
143d
Days
Class 1
Risk

K834116 is an FDA 510(k) clearance for the DEAE-DEXTRAN IN PBS. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 20, 1984 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2220 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bartels Immunodiagnostic Supplies, Inc. devices

FDA 510(k) Submission Details - K834116

510(k) Number K834116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date April 20, 1984
Days to Decision 143 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 102d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

KIT Device Classification - Class 1, General Controls

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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 - KIT Media And Components, Synthetic Cell And Tissue Culture

All 335
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K834116.
HANKS BALANCED SALTS-HBSS H2387
K842002 · Sigma Chemical Co. · Jun 1984
TRANSPORTER VIRAL TRANSPORT MEDIUM
K840744 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
DULBECCO'S PHOSPHATE BUFFERED SALINE
K841744 · Sigma Chemical Co. · May 1984
TISSUE CULTURE REFEEDING MEDIUM
K834113 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
PBS W/MG+2 & CA+2
K834136 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX
K834122 · Bartels Immunodiagnostic Supplies, Inc. · Feb 1984