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FDA 510(k)

COPAN VIRAL TRANSYSTEM

K-Number: K001780 · 2001-07-31

ApplicantCopan Diagnostics, Inc.
Decision Date2001-07-31
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPAN VIRAL TRANSYSTEM 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 2001-07-31 under 510(k) number K001780. 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 VIRAL TRANSYSTEM?

COPAN VIRAL TRANSYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Copan Diagnostics, Inc.. The 510(k) number is K001780.

When did COPAN VIRAL TRANSYSTEM receive FDA 510(k) clearance?

COPAN VIRAL TRANSYSTEM received FDA 510(k) clearance on 2001-07-31, under 510(k) number K001780.

Who is the listed applicant for COPAN VIRAL TRANSYSTEM?

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 VIRAL TRANSYSTEM?

The FDA product code for COPAN VIRAL TRANSYSTEM 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) SYSTEMK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMK946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMK946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMK946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

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Related Devices (Code: JSM)

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.

K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd.K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd.K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia SpaK220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd.

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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