Cleared Traditional

K840332 - CAMPYLOBACTER AGAR BASE

K840332 is an FDA 510(k) clearance for CAMPYLOBACTER AGAR BASE, manufactured by Oxoid U.S.A., Inc.. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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

FDA 510(k) Submission Details - K840332

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

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 271
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K840332.
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