Cleared Traditional

CAMPYLOBACTER AGAR BASE (K840332) - FDA 510(k) Clearance

Class I Microbiology device.

K840332 · Oxoid U.S.A., Inc. · Microbiology device
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May 1984
Decision
107d
Days
Class 1
Risk

K840332 is an FDA 510(k) clearance for the CAMPYLOBACTER AGAR BASE. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K840332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date May 11, 1984
Days to Decision 107 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
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 306
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K840332.
GBNA MEDIUM
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K871702 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
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K871357 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
ANAEROBIC PEA BLOOD AGAR
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BACTEROIDES BILE ESCULIN AGAR
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CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
K871093 · bioMerieux, Inc. · Apr 1987