Cleared Traditional

BILE ESCULIN AZIDE AGAR (K820553) - FDA 510(k) Clearance

Class I Microbiology device.

K820553 · American Laboratory Supply, Inc. · Microbiology device
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Mar 1982
Decision
14d
Days
Class 1
Risk

K820553 is an FDA 510(k) clearance for the BILE ESCULIN AZIDE AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by American Laboratory Supply, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1982 after a review of 14 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 American Laboratory Supply, Inc. devices

Submission Details

510(k) Number K820553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date March 16, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
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.

Regulatory Peers - JSI Culture Media, Selective And Differential

All 59
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K820553.
MACCONKEY AGAR
K830071 · bioMerieux, Inc. · Feb 1983
HEKTOEN ENTERIC AGAR
K830072 · bioMerieux, Inc. · Feb 1983
BISMUTH SULFITE AGAR
K830079 · bioMerieux, Inc. · Feb 1983
ENDO AGAR
K811648 · Acumedia Manufacturers, Inc. · Jul 1981
SF BROTH
K811331 · Acumedia Manufacturers, Inc. · May 1981
BRAIN HEART CC AGAR
K811332 · Acumedia Manufacturers, Inc. · May 1981