Cleared Traditional

K946287 - COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

K946287 is an FDA 510(k) clearance for COPAN VENTURI TRANSYSTEM AMIES MEDIUM W..., manufactured by Copan Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K946287 · Copan Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
73d
Days
Class 1
Risk

K946287 is an FDA 510(k) clearance for the COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Copan Diagnostics, Inc. devices

FDA 510(k) Submission Details - K946287

510(k) Number K946287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date March 10, 1995
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 69
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K946287.
10B ARGININE BROTH
K961046 · Remel, L.P. · Sep 1996
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K962843 · Starplex Scientific, Inc. · Sep 1996
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
BACTI-SWAB
K910180 · Remel Co. · May 1991