Cleared Traditional

K820553 - BILE ESCULIN AZIDE AGAR

K820553 is an FDA 510(k) clearance for BILE ESCULIN AZIDE AGAR, manufactured by American Laboratory Supply, Inc.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K820553 · American Laboratory Supply, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K820553

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

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 232
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K820553.
#2007 XLD
K820801 · Biomedica, Inc. · Apr 1982
#2009 BIGGY AGAR
K820802 · Biomedica, Inc. · Apr 1982
EOSIN METHYLENE BLUE AGAR
K820552 · American Laboratory Supply, Inc. · Mar 1982
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · Hoffmann-La Roche, Inc. · Oct 1981
SMITH'S SYSTEMIC FUNGAL MEDIUM
K812187 · American Scientific Products · Aug 1981
EOSIN METHYLENE BLUE AGAR (LEVINE)
K811642 · Hardy Media · Jul 1981