Cleared Traditional

AGAR P (K823102) - FDA 510(k) Clearance

Class I Microbiology device.

K823102 · Dms Laboratories · Microbiology device
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Dec 1982
Decision
44d
Days
Class 1
Risk

K823102 is an FDA 510(k) clearance for the AGAR P. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Dms Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 44 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 Dms Laboratories devices

Submission Details

510(k) Number K823102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1982
Decision Date December 03, 1982
Days to Decision 44 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 102d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-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 - JSJ Culture Media, Selective And Non-differential

All 65
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K823102.
MYCOBIOTIC AGAR
K830069 · bioMerieux, Inc. · Feb 1983
CAMPYLOCACTER SELECTIVE AGAR BLASER'S
K830076 · bioMerieux, Inc. · Feb 1983
BILE ESCULIN AGAR
K830081 · bioMerieux, Inc. · Feb 1983
CAMPYLOBACTER THIOGLYCOLLATE MED W/5
K820060 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1982
MACCONKEY BROTH
K811650 · Acumedia Manufacturers, Inc. · Jul 1981
AZIDE BLOOD AGAR BASE
K811733 · Acumedia Manufacturers, Inc. · Jul 1981