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510(k) K844762

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 by Wellcome Diagnostics — Product Code GTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1985
Date Received
December 7, 1984
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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  • K861628 — WELLCOZYME ROTAVIRUS WZ01 (January 21, 1987)
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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)
  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
  • K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (February 4, 1986)
  • K844999 — PHADEBACT CSF TEST (October 17, 1985)
  • K851691 — WILLCOGEN MENINGITIDIS KIT ZL25 (June 10, 1985)
  • K844407 — DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (January 25, 1985)