Copan Venturi Transystem Amies Medium Without Charcoal

No FDA recalls found in the data synced 24 Oct 2026.

510(k) Number

K946287 ↗

FDA Product Code

JSM

Device Class

Class I

Regulation

21 CFR Part 866.2390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Copan Viral Transystem

  Class I

  FDA 510(k) K001780 Active Cleared 31 Jul 2001

• Copan Venturi Transystem Liquid Amies Medium

  Class I

  FDA 510(k) K946288 Active Cleared 10 Mar 1995

• Copan Easy-Swab Collection and Transport System Open recall

  Class I

  FDA 510(k) K993161 Active Cleared 9 Nov 1999

• Copan Venturi Transystem Liquid Stuarts Medium Open recall

  Class I

  FDA 510(k) K946283 Active Cleared 10 Mar 1995

• Copan Venturi Transystem Stuarts Medium

  Class I

  FDA 510(k) K946285 Active Cleared 10 Mar 1995

• Copan Venturi Transystem Amies Medium with Charcoal

  Class I

  FDA 510(k) K946284 Active Cleared 10 Mar 1995

See all devices from Copan Diagnostics, Inc. →