# K972449: Copan Venturi Transystem Amies Medium with Charcoal

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Aug 20, 1997 after 51 days
- Product code: JSL (Culture Media, Anaerobic Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854986 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960997: Starswab Culture Collection and Transport System, Starplex Scientific, Inc. (1996) Summary page 2.
- K854986: BBL Port-a-Cul Aerobic Transport Sys, Modified Stu, Bd Becton Dickinson Vacutainer Systems Preanalytic (1986) Summary page 2.

## Indications for use
The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and (luring their transport from the coHecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for l)acteriological examination. Copan Venturi Transystem Amies Medium With Charcoal is Aesigned to support the viability of a wide variety of clim’cafly important aerobic and anaerobic bacteria.

Source page: https://510kreport.com/device/K972449
Methodology: https://510kreport.com/methodology