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510(k) K121039

COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM by Copan Flock Technologies — Product Code JTW

K121039 is an FDA 510(k) premarket notification submitted by Copan Flock Technologies for the device "COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 2012. The device falls under product code JTW (System, Transport, Aerobic), a Class I device regulated under 21 CFR 866.2900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2012
Date Received
April 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Transport, Aerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances for product code JTW

  • K061301 — COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM (June 23, 2006)
  • K022874 — GEN-PROBE APTIMA COMBO 2 ASSAY (September 17, 2002)
  • K013819 — URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (February 28, 2002)
  • K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (November 9, 1999)
  • K983244 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (November 30, 1998)
  • K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (April 26, 1996)
  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)
  • K904773 — P AND T MEDIUM (December 4, 1990)
  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)

FDA data resources