Cleared Traditional

K834206 - EUGONIC AGAR

K834206 is the FDA 510(k) clearance for EUGONIC AGAR by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K834206 · Acumedia Manufacturers, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
29d
Days
Class 1
Risk

K834206 is an FDA 510(k) clearance for the EUGONIC AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K834206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date January 03, 1984
Days to Decision 29 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
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K834206.
EMMON 3 SABDEX
K834322 · Hardy Media · Jan 1984
POTATO DEXTROSE AGAR
K834323 · Hardy Media · Jan 1984
BRUCELLA MEDIA
K834006 · Micro Media Laboratories · Jan 1984
POTATO DEXTROSE AGAR
K834014 · Micro Media Laboratories · Dec 1983
GN BROTH
K834016 · Micro Media Laboratories · Dec 1983
BRUCELLA AGAR MODIFIED
K833299 · Acumedia Manufacturers, Inc. · Nov 1983