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510(k) K220052

Copan FecalSwab Collection, Transport and Preservation System by Copan Italia Spa — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2022
Date Received
January 6, 2022
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

Other clearances by Copan Italia Spa

  • K232565 — UriSponge™ (October 11, 2024)
  • K232357 — Copan Universal Transport Medium (UTM-RT) System (April 25, 2024)
  • K201849 — eNAT molecular collection and preservation medium (September 17, 2020)
  • K180052 — UriSwab-Urine Collection, Transport and Preservation System (March 23, 2018)
  • K142094 — COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (April 10, 2015)
  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)
  • K972449 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (August 20, 1997)

Other clearances for product code JSM

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  • K250205 — Babio® Virus Transport Kit (Non-inactivating) (September 22, 2025)
  • K242576 — AllTest Viral Transport Medium (April 4, 2025)
  • K232565 — UriSponge™ (October 11, 2024)
  • K220908 — Ensol EnTM Specimen Collection and Transport System (August 29, 2024)
  • K240235 — OmniTrans Transport System (August 19, 2024)
  • K233534 — Viral Transport Medium (August 2, 2024)
  • K233449 — Avantik VTM (July 15, 2024)
  • K232454 — Viral Transport Media (VTM) (May 3, 2024)
  • K232357 — Copan Universal Transport Medium (UTM-RT) System (April 25, 2024)