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510(k) K833063

WELLCOGEN N. MENINGITIDIS A,C,Y W135 by Wellcome Diagnostics — Product Code GTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
September 9, 1983
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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  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
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Other clearances for product code GTJ

  • K952791 — DIRECTIGEN MENINGITIS COMBO TEST (May 30, 1996)
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  • 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)