Cleared Traditional

K855198 - INDI KWIK (TM) CO/TWO KIT

K855198 is an FDA 510(k) clearance for INDI KWIK (TM) CO/TWO KIT, manufactured by Micro-Bio-Logics. The device is a Class 1 Microbiology device with product code JTR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K855198 · Micro-Bio-Logics · Microbiology device
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Jan 1986
Decision
18d
Days
Class 1
Risk

K855198 is an FDA 510(k) clearance for the INDI KWIK (TM) CO/TWO KIT. Classified as Kit, Quality Control For Culture Media (product code JTR), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2480 - 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 Micro-Bio-Logics devices

FDA 510(k) Submission Details - K855198

510(k) Number K855198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1985
Decision Date January 14, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JTR Device Classification - Class 1, General Controls

Product Code JTR Kit, Quality Control For Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2480
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 - JTR Kit, Quality Control For Culture Media

Devices cleared under the same product code (JTR) and FDA review panel - the closest regulatory comparables to K855198.
PROTECT T.M.
K871121 · Pro-Lab, Inc. · Apr 1987
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS
K842579 · Biological & Environmental Control Laboratories · Jul 1984
LYOPHILIZED MICROORGANISMS
K831653 · Austin Biological Laboratories · Jul 1983
BIO-CHECK GRAM STAIN CONTROL
K821660 · American Scientific Products · Jun 1982
GC DISK
K812698 · Remel Co. · Oct 1981