Cleared Traditional

K834319 - BHI AGAR

K834319 is the FDA 510(k) clearance for BHI AGAR by Hardy Media. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K834319 · Hardy Media · Microbiology device
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Jan 1984
Decision
35d
Days
Class 1
Risk

K834319 is an FDA 510(k) clearance for the BHI AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Hardy Media (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 35 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 Hardy Media devices

Submission Details

510(k) Number K834319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1983
Decision Date January 13, 1984
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
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 K834319.
CTA MEDIUM TUBE
K834425 · Otisville Biotech, Inc. · Jan 1984
LOEFFLER MEDIUM TUBE
K834426 · Otisville Biotech, Inc. · Jan 1984
THIOGEL MEDIUM TUBE
K834427 · Otisville Biotech, Inc. · Jan 1984
THIO W/SUPPLEMENT
K834321 · Hardy Media · Jan 1984
EMMON 3 SABDEX
K834322 · Hardy Media · Jan 1984
POTATO DEXTROSE AGAR
K834323 · Hardy Media · Jan 1984