Cleared Traditional

K811478 - EMB AGAR, LEVINE (FDA 510(k) Clearance)

Class I Toxicology device.

K811478 · Biomedia, Inc. · Toxicology device
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Jun 1981
Decision
23d
Days
Class 1
Risk

K811478 is an FDA 510(k) clearance for the EMB AGAR, LEVINE. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Biomedia, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2360 - the FDA toxicology 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 Biomedia, Inc. devices

Submission Details

510(k) Number K811478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1981
Decision Date June 18, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 87d · This submission: 23d
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.