Cleared Traditional

K834015 - SELENITE BROTH (FDA 510(k) Clearance)

Class I Microbiology device.

K834015 · Micro Media Laboratories · Microbiology device
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Dec 1983
Decision
31d
Days
Class 1
Risk

K834015 is an FDA 510(k) clearance for the SELENITE BROTH. Classified as Culture Media, Selective Broth (product code JSD), Class I - General Controls.

Submitted by Micro Media Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 31 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.

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Submission Details

510(k) Number K834015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date December 22, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSD Culture Media, Selective Broth
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.