Cleared Traditional

K861259 - MACCONKEY W/MUG

K861259 is the FDA 510(k) clearance for MACCONKEY W/MUG by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K861259 · Remel Co. · Microbiology device
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Apr 1986
Decision
8d
Days
Class 1
Risk

K861259 is an FDA 510(k) clearance for the MACCONKEY W/MUG. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Remel Co. devices

Submission Details

510(k) Number K861259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1986
Decision Date April 11, 1986
Days to Decision 8 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
94d faster than avg
Panel avg: 102d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K861259.
ONPG SOLUTION
K863601 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
DISPENS-O-DISC DIFFERENTIATION DISKS PYR
K862570 · Difco Laboratories, Inc. · Jul 1986
SENSITITRE AUTO ID PLATE, AP70
K861058 · Gibco Laboratories Life Technologies, Inc. · May 1986
DIFFERENTIATION DISKS RIFAMPIN 15 MCG
K860560 · Difco Laboratories, Inc. · Mar 1986
DIFFERENTIATION DISKS PENICILLIN G 2 UNITS
K860561 · Difco Laboratories, Inc. · Mar 1986
DIFFERENTIATION DISKS COLISTIN 10 MCG
K860562 · Difco Laboratories, Inc. · Mar 1986