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510(k) K142094

COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM by Copan Italia Spa — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2015
Date Received
August 1, 2014
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)
  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)
  • K972449 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (August 20, 1997)

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