Cleared Traditional

K842000 - PRIMARY RABBITT KIDNEY CELL CULTURE

K842000 is an FDA 510(k) clearance for PRIMARY RABBITT KIDNEY CELL CULTURE, manufactured by Bartels Immunodiagnostic Supplies, Inc.. The device is a Class 1 Microbiology device with product code KIR cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K842000 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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Jun 1984
Decision
37d
Days
Class 1
Risk

K842000 is an FDA 510(k) clearance for the PRIMARY RABBITT KIDNEY CELL CULTURE. 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 June 22, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2280 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bartels Immunodiagnostic Supplies, Inc. devices

FDA 510(k) Submission Details - K842000

510(k) Number K842000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1984
Decision Date June 22, 1984
Days to Decision 37 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
65d faster than avg
Panel avg: 102d · This submission: 37d
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 K842000.
HEK
K842584 · Viromed Laboratories, Inc. · Jul 1984
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
WI-38
K841806 · Viromed Laboratories, Inc. · Jun 1984
ULTRACLONE ECL-01-800 CELL LINE
K841337 · Earl-Clay Laboratories, Inc. · May 1984
ULTRACLONE ECL-01-600 CELL LINE
K841338 · Earl-Clay Laboratories, Inc. · May 1984