Cleared Traditional

K841998 - IMR-90-DIPLOID-HUMAN FETAL LUNG CELL

K841998 is the FDA 510(k) clearance for IMR-90-DIPLOID-HUMAN FETAL LUNG CELL by Bartels Immunodiagnostic Supplies, Inc.. It is a Class 1 Microbiology device (product code KIR) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K841998 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
42d
Days
Class 1
Risk

K841998 is an FDA 510(k) clearance for the IMR-90-DIPLOID-HUMAN FETAL LUNG CELL. 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 27, 1984 after a review of 42 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

Submission Details

510(k) Number K841998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1984
Decision Date June 27, 1984
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 79
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K841998.
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292 · Difco Laboratories, Inc. · Feb 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
K860293 · Difco Laboratories, Inc. · Feb 1986
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · Difco Laboratories, Inc. · Jan 1985
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN
K834117 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984