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510(k) K841308

DIRECTIGEN MENNINGITIS TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
March 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Groups, N. Meningitidis
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
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  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code GTI

  • K920274 — DIRECTIGEN NEISSERIA MENINGITIDIS TEST (March 18, 1992)