Cleared Traditional

K852789 - AEROMONAS AGAR(XDCA)

K852789 is an FDA 510(k) clearance for AEROMONAS AGAR(XDCA), manufactured by Gibco Laboratories Life Technologies, Inc.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K852789 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Jul 1985
Decision
18d
Days
Class 1
Risk

K852789 is an FDA 510(k) clearance for the AEROMONAS AGAR(XDCA). Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 18 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 Gibco Laboratories Life Technologies, Inc. devices

FDA 510(k) Submission Details - K852789

510(k) Number K852789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date July 19, 1985
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
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 K852789.
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APL HEKTOEN ENTERIC AGAR
K853235 · Apl Medical Supplies · Aug 1985
SF BROTH
K851594 · Preferred Micro-Media · May 1985
BILE ESCULIN AZIDE AGAR
K851577 · Preferred Micro-Media · May 1985
BILE ESCULIN AGAR
K851578 · Preferred Micro-Media · May 1985