COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM— 510(k) K946283

Name: FDA 510(k) clearance K946283
Creator: U.S. Food and Drug Administration
Published: 1995-03-10

Substantially Equivalent

Copan Diagnostics, Inc.

FDA 510(k) clearance K946283 for COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM, 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 ↗

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K946284 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL1995-03-10

Recalls naming K946283

K-number listed on FDA's recall record

Z-2584-2024 — Cepheid, Sample Collection Device, Part: 900-0370Class II·Ongoing·Cepheid·20240620

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K946283.

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