Cleared Traditional

K832582 - MYCOSEL AGAR

K832582 is the FDA 510(k) clearance for MYCOSEL AGAR by Acuderm, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K832582 · Acuderm, Inc. · Microbiology device
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Sep 1983
Decision
41d
Days
Class 1
Risk

K832582 is an FDA 510(k) clearance for the MYCOSEL AGAR. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Acuderm, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Acuderm, Inc. devices

Submission Details

510(k) Number K832582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date September 12, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 240
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K832582.
CLOSTRIDIUM DIFFICILE
K833136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1983
LOWENSTEIN-JENSEN MEDIUM BASE
K833220 · Acumedia Manufacturers, Inc. · Oct 1983
BRILLIANT GREEN AGAR PLATE
K832536 · Otisville Biotech, Inc. · Oct 1983
CLOSTRIDIUM DIFFICLE MEDIA
K831279 · Gibco Laboratories Life Technologies, Inc. · May 1983
CLOSTRIDIUM DIFFICILE MEDIA
K831220 · Gibco Laboratories Life Technologies, Inc. · May 1983
SELECTIVE LEGIONELLA MEDIA
K823885 · Gibco Laboratories Life Technologies, Inc. · Mar 1983