Cleared Traditional

K820060 - CAMPYLOBACTER THIOGLYCOLLATE MED W/5

K820060 is an FDA 510(k) clearance for CAMPYLOBACTER THIOGLYCOLLATE MED W/5, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820060 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
17d
Days
Class 1
Risk

K820060 is an FDA 510(k) clearance for the CAMPYLOBACTER THIOGLYCOLLATE MED W/5. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 17 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K820060

510(k) Number K820060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1982
Decision Date January 28, 1982
Days to Decision 17 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
85d faster than avg
Panel avg: 102d · This submission: 17d
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 259
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K820060.
COLUMBIZ CNA AGAR W/15% SHEEP BLOOD
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ANAEROBE BLOOD AGAR W/KANAMYCIN & VANCO
K820555 · American Laboratory Supply, Inc. · Mar 1982
CIN AGAR BASE
K820295 · Gibco Laboratories Life Technologies, Inc. · Mar 1982
ANAEROBIC CNA BLOOD AGAR
K812796 · Isle Media and Sterile Products, Inc. · Oct 1981
MACCONKEY BROTH
K811650 · Acumedia Manufacturers, Inc. · Jul 1981
AZIDE BLOOD AGAR BASE
K811733 · Acumedia Manufacturers, Inc. · Jul 1981