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FDA 510(k)

COPAN VENTURI TRANSYSTEM STUARTS MEDIUM

K-Number: K946285 · 1995-03-10

ApplicantCopan Diagnostics, Inc.
Decision Date1995-03-10
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPAN VENTURI TRANSYSTEM STUARTS MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Copan Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K946285. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPAN VENTURI TRANSYSTEM STUARTS MEDIUM?

COPAN VENTURI TRANSYSTEM STUARTS MEDIUM is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Copan Diagnostics, Inc.. The 510(k) number is K946285.

When did COPAN VENTURI TRANSYSTEM STUARTS MEDIUM receive FDA 510(k) clearance?

COPAN VENTURI TRANSYSTEM STUARTS MEDIUM received FDA 510(k) clearance on 1995-03-10, under 510(k) number K946285.

Who is the listed applicant for COPAN VENTURI TRANSYSTEM STUARTS MEDIUM?

The FDA 510(k) record lists Copan Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPAN VENTURI TRANSYSTEM STUARTS MEDIUM?

The FDA product code for COPAN VENTURI TRANSYSTEM STUARTS MEDIUM is JSM.

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Other records listing Copan Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMK042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMK001780COPAN VIRAL TRANSYSTEMK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMK946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMK946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

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Related Devices (Code: JSM)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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