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510(k) K895187

FDL, INC.'S TRANSPORT SYSTEM by Fairleigh Dickinson Laboratories, Inc. — Product Code JTW

K895187 is an FDA 510(k) premarket notification submitted by Fairleigh Dickinson Laboratories, Inc. for the device "FDL, INC.'S TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code JTW (System, Transport, Aerobic), a Class I device regulated under 21 CFR 866.2900. Fairleigh Dickinson Laboratories, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
August 11, 1989
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 Fairleigh Dickinson Laboratories, Inc.

  • K896032 — MODIFIED ELISA FOR CHLAMYDIA (January 29, 1990)
  • K883266 — FDL ELISA FOR CHLAMYDIA (October 25, 1988)
  • K881502 — BREWER GEL FOR CAMPYLOBACTER (April 27, 1988)
  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K853307 — DIRECT ELISA FOR HERPES SIMPLEX VIRUS (December 23, 1985)
  • K850251 — ROTALOK SURGICAL HAND TABLE (February 28, 1985)

Other clearances for product code JTW

  • K121039 — COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (May 25, 2012)
  • 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)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)

FDA data resources