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510(k) K920274

DIRECTIGEN NEISSERIA MENINGITIDIS TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
January 22, 1992
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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Other clearances for product code GTI

  • K841308 — DIRECTIGEN MENNINGITIS TEST KIT (May 2, 1984)