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FDA 510(k)

COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

K-Number: K121039 · 2012-05-25

ApplicantCopan Flock Technologies
Decision Date2012-05-25
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Copan Flock Technologies. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K121039. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM?

COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Copan Flock Technologies. The 510(k) number is K121039.

When did COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM receive FDA 510(k) clearance?

COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM received FDA 510(k) clearance on 2012-05-25, under 510(k) number K121039.

Who is the listed applicant for COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM?

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

What is the FDA product code for COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM?

The FDA product code for COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM is JTW.

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Related Devices (Code: JTW)

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 SYSTEMCopan Diagnostics, Inc.K022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLCK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, Inc.K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Difco Laboratories, Inc.

Official Source

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

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