Cleared Traditional

K822737 - MYCOTRIUM-RS (FDA 510(k) Clearance)

Class I Microbiology device.

K822737 · Hana Biologics, Inc. · Microbiology device
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Dec 1982
Decision
85d
Days
Class 1
Risk

K822737 is an FDA 510(k) clearance for the MYCOTRIUM-RS. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Hana Biologics, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 85 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 Hana Biologics, Inc. devices

Submission Details

510(k) Number K822737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1982
Decision Date December 03, 1982
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And 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.