Cleared Traditional

K852789 - AEROMONAS AGAR(XDCA)

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

K852789 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 187
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K852789.
BIOTIS BISMUTH SULFITE AGAR
K860402 · Otisville Biotech, Inc. · Feb 1986
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K855110 · Gibco Laboratories Life Technologies, Inc. · Jan 1986
TERGITOL 7 AGAR
K853691 · Micro Media Laboratories · Sep 1985
BIOTIS CHOCOLATE TELLURITE
K850565 · Otisville Biotech, Inc. · Mar 1985
BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE
K850552 · Hardy Media · Mar 1985
BRILLANT GREEN AGAR
K844930 · American Laboratory Supply, Inc. · Feb 1985