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510(k) K232357

Copan Universal Transport Medium (UTM-RT) System by Copan Italia Spa — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2024
Date Received
August 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

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  • K180052 — UriSwab-Urine Collection, Transport and Preservation System (March 23, 2018)
  • K142094 — COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (April 10, 2015)
  • K972449 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (August 20, 1997)
  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)

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