Cleared Traditional

K834136 - PBS W/MG+2 & CA+2

K834136 is an FDA 510(k) clearance for PBS W/MG+2 & CA+2, manufactured by Bartels Immunodiagnostic Supplies, Inc.. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K834136 · Bartels Immunodiagnostic Supplies, Inc. · Pathology device
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Mar 1984
Decision
113d
Days
Class 1
Risk

K834136 is an FDA 510(k) clearance for the PBS W/MG+2 & CA+2. 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 March 22, 1984 after a review of 113 days - within the typical 510(k) review window.

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

View all Bartels Immunodiagnostic Supplies, Inc. devices

FDA 510(k) Submission Details - K834136

510(k) Number K834136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1983
Decision Date March 22, 1984
Days to Decision 113 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 77d · This submission: 113d
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 K834136.
DULBECCO'S PHOSPHATE BUFFERED SALINE
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DEAE-DEXTRAN IN PBS
K834116 · Bartels Immunodiagnostic Supplies, Inc. · Apr 1984
TISSUE CULTURE REFEEDING MEDIUM
K834113 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX
K834122 · Bartels Immunodiagnostic Supplies, Inc. · Feb 1984
MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM
K833389 · Sigma Chemical Co. · Nov 1983
TYRODE'S SALT SOLUTION W/SODIUM BICAR
K833390 · Sigma Chemical Co. · Nov 1983