Cleared Traditional

K834117 - HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN

K834117 is an FDA 510(k) clearance for HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN, manufactured by Bartels Immunodiagnostic Supplies, Inc.. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K834117 · Bartels Immunodiagnostic Supplies, Inc. · Pathology device
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Mar 1984
Decision
114d
Days
Class 1
Risk

K834117 is an FDA 510(k) clearance for the HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN. Classified as Cells, Animal And Human, Cultured (product code KIR), 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 114 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - 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 - K834117

510(k) Number K834117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date March 22, 1984
Days to Decision 114 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
37d slower than avg
Panel avg: 77d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

KIR Device Classification - Class 1, General Controls

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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 - KIR Cells, Animal And Human, Cultured

All 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K834117.
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K841666 · Viromed Laboratories, Inc. · May 1984
MCCOY CELLS
K834119 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
LLC-MK2-RHESUS MONKEY KIDNEY CELLS
K834120 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
WI-38 HUMAN LUNG CELLS
K834123 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984