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510(k) K972449

COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL by Copan Italia Spa — Product Code JSL

K972449 is an FDA 510(k) premarket notification submitted by Copan Italia Spa for the device "COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL". The FDA issued a decision of Substantially Equivalent on August 20, 1997. The device falls under product code JSL (Culture Media, Anaerobic Transport), a Class I device regulated under 21 CFR 866.2390. Copan Italia Spa has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
June 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Anaerobic 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)
  • K220052 — Copan FecalSwab Collection, Transport and Preservation System (December 16, 2022)
  • 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)

Other clearances for product code JSL

  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K925450 — BIONOR TRANSPORTMEDIUM (June 25, 1993)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (April 4, 1984)
  • K834357 — ANA TRANS TUBE & SWABS STERILE PACK (January 31, 1984)
  • K770840 — PRE-REDUCED ANAEROBIC MEDIA (June 8, 1977)
  • K770650 — PRE-DUCED CULTURE MEDIA (April 15, 1977)

FDA data resources