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510(k) K915330

DIRECTIGEN MENINGITIS COMBO TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1992
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, 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 GTJ

  • K952791 — DIRECTIGEN MENINGITIS COMBO TEST (May 30, 1996)
  • K910210 — SLIDEX MENINGITE-KIT 5 (August 12, 1991)
  • K885004 — BACTIGEN(R) N. MENINGITIDIS (February 7, 1989)
  • K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (March 17, 1987)
  • K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (February 4, 1986)
  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
  • K844999 — PHADEBACT CSF TEST (October 17, 1985)
  • K851691 — WILLCOGEN MENINGITIDIS KIT ZL25 (June 10, 1985)
  • K844762 — MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (June 4, 1985)
  • K844407 — DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (January 25, 1985)