COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL— 510(k) K946287

Name: FDA 510(k) clearance K946287
Creator: U.S. Food and Drug Administration
Published: 1995-03-10

Substantially Equivalent

Copan Diagnostics, Inc.

FDA 510(k) clearance K946287 for COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL, Substantially Equivalent on 1995-03-10. Applicant: Copan Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Copan Diagnostics, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1994-12-27
Decision date: 1995-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSM

view all

K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device2025-11-26
K250205 — Babio® Virus Transport Kit (Non-inactivating)2025-09-22
K242576 — AllTest Viral Transport Medium2025-04-04
K232565 — UriSponge2024-10-11
K220908 — Ensol EnTM Specimen Collection and Transport System2024-08-29

More clearances from Copan Diagnostics, Inc.

view all

K061301 — COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM2006-06-23
K042970 — COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM2004-12-07
K001780 — COPAN VIRAL TRANSYSTEM2001-07-31
K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM1999-11-09
K946283 — COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM1995-03-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.