Cleared Traditional

K802753 - CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)

K802753 is the FDA 510(k) clearance for CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) by Oxoid U.S.A., Inc.. It is a Class 1 Chemistry device (product code JSK) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K802753 · Oxoid U.S.A., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
38d
Days
Class 1
Risk

K802753 is an FDA 510(k) clearance for the CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.). 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 December 11, 1980 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2450 - the FDA in vitro diagnostics and chemistry 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 Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K802753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1980
Decision Date December 11, 1980
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 56
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K802753.
PANCREATIC HYDROLYSATE OF HEART MUSCLE
K811361 · Acumedia Manufacturers, Inc. · May 1981
VITOX
K810932 · Oxoid U.S.A., Inc. · Apr 1981
PACT SUPPLEMENT
K810591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
STERILE GC SUPPLEMENT
K800252 · Oxoid U.S.A., Inc. · Mar 1980
MYCOPLASMA SUPPLEMENT G
K800253 · Oxoid U.S.A., Inc. · Mar 1980
MYCOPLASMA SUPPLEMENT P
K800254 · Oxoid U.S.A., Inc. · Mar 1980