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510(k) K843341

GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
August 27, 1984
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

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  • 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)