Cleared Traditional

K850658 - CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE

K850658 is an FDA 510(k) clearance for CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR..., manufactured by Oxoid U.S.A., Inc.. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K850658 · Oxoid U.S.A., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
33d
Days
Class 1
Risk

K850658 is an FDA 510(k) clearance for the CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Oxoid U.S.A., Inc. devices

FDA 510(k) Submission Details - K850658

510(k) Number K850658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date March 20, 1985
Days to Decision 33 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
69d faster than avg
Panel avg: 102d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

JSG Device Classification - Class 1, General Controls

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 189
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K850658.
THIOGLYCOLLATE WITHOUT INDICATOR
K851598 · Preferred Micro-Media · May 1985
TRYPTIC SOY BROTH
K851601 · Preferred Micro-Media · May 1985
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · Roche Diagnostic Systems, Inc. · Apr 1985
BRAIN HEART INFUSION BROTH
K850842 · Micro Media Laboratories · Mar 1985
THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN
K850847 · Micro Media Laboratories · Mar 1985
BRAIN HEART INFUSION AGAR
K850848 · Micro Media Laboratories · Mar 1985