Cleared Traditional

K840330 - PRESTON CAMPYLOBACTER SELECTIVE SUPP

K840330 is an FDA 510(k) clearance for PRESTON CAMPYLOBACTER SELECTIVE SUPP, manufactured by Oxoid U.S.A., Inc.. The device is a Class 1 Microbiology device with product code JSK cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K840330 · Oxoid U.S.A., Inc. · Microbiology device
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May 1984
Decision
107d
Days
Class 1
Risk

K840330 is an FDA 510(k) clearance for the PRESTON CAMPYLOBACTER SELECTIVE SUPP. Classified as Supplement, Culture Media (product code JSK), 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 866.2450 - 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 - K840330

510(k) Number K840330 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.

JSK Device Classification - Class 1, General Controls

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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 - JSK Supplement, Culture Media

All 65
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K840330.
CAMPYLOBACTER SUPPLEMENT -SKIRROW
K850306 · Pro-Lab, Inc. · Mar 1985
CAMPYLOBACTER SUPPLEMENT-BLASER/WANG
K850307 · Pro-Lab, Inc. · Mar 1985
C.L.A.T.
K850308 · Pro-Lab, Inc. · Mar 1985
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · Oxoid U.S.A., Inc. · May 1984
CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
K834115 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984