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510(k) K904773

P AND T MEDIUM by Gibson Laboratories, Inc. — Product Code JTW

K904773 is an FDA 510(k) premarket notification submitted by Gibson Laboratories, Inc. for the device "P AND T MEDIUM". The FDA issued a decision of Substantially Equivalent on December 4, 1990. The device falls under product code JTW (System, Transport, Aerobic), a Class I device regulated under 21 CFR 866.2900. Gibson Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1990
Date Received
October 22, 1990
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 Gibson Laboratories, Inc.

  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K953247 — GIBSON ID A.E. TEST (November 20, 1995)
  • K905120 — SAF FIXATIVE (December 17, 1990)

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)
  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)

FDA data resources