Cleared Traditional

K834006 - BRUCELLA MEDIA (FDA 510(k) Clearance)

Class I Microbiology device.

K834006 · Micro Media Laboratories · Microbiology device
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Jan 1984
Decision
43d
Days
Class 1
Risk

K834006 is an FDA 510(k) clearance for the BRUCELLA MEDIA. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Micro Media Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 43 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.

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Submission Details

510(k) Number K834006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date January 03, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 102d · This submission: 43d
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.