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510(k) K061301

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM by Copan Diagnostics, Inc. — Product Code JTW

K061301 is an FDA 510(k) premarket notification submitted by Copan Diagnostics, Inc. for the device "COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code JTW (System, Transport, Aerobic), a Class I device regulated under 21 CFR 866.2900. Copan Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
May 10, 2006
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 by Copan Diagnostics, Inc.

  • K042970 — COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM (December 7, 2004)
  • K001780 — COPAN VIRAL TRANSYSTEM (July 31, 2001)
  • K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (November 9, 1999)
  • K946286 — COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM (March 10, 1995)
  • K946287 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (March 10, 1995)
  • K946285 — COPAN VENTURI TRANSYSTEM STUARTS MEDIUM (March 10, 1995)
  • K946283 — COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM (March 10, 1995)
  • K946288 — COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM (March 10, 1995)
  • K946284 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (March 10, 1995)

Other clearances for product code JTW

  • K121039 — COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (May 25, 2012)
  • 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