Cleared Traditional

#4005 TSA SLANT-TUBED MEDIA (K820791) - FDA 510(k) Clearance

Class I Microbiology device.

K820791 · Biomedica, Inc. · Microbiology device
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Apr 1982
Decision
16d
Days
Class 1
Risk

K820791 is an FDA 510(k) clearance for the #4005 TSA SLANT-TUBED MEDIA. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Biomedica, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982 after a review of 16 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 Biomedica, Inc. devices

Submission Details

510(k) Number K820791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date April 08, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
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 208
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K820791.
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BLOOD AGAR BASE W/LOW PH
K881532 · Acumedia Manufacturers, Inc. · Apr 1988