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510(k) K771562

AGGLUTINATING SERUM W135 by Burroughs Wellcome Co. — Product Code GTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1977
Date Received
August 15, 1977
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

Other clearances by Burroughs Wellcome Co.

  • K820069 — WELLCOGEN GROUP B (February 18, 1982)
  • K813508 — SAC-CEL (December 29, 1981)
  • K810215 — DAC-CEL HCG (April 17, 1981)
  • K810214 — DAC-CEL DIAGNATAL (March 6, 1981)
  • K810212 — DAC-CEL T3 UPTAKE (February 10, 1981)
  • K810213 — DAC-CEL TSH (February 10, 1981)
  • K791232 — DAC-CEL T3 (September 4, 1979)
  • K791231 — DAC-CEL T4 (September 4, 1979)
  • K781607 — STREP-TEX (October 17, 1978)
  • K780873 — THYMUNE-M (June 14, 1978)

Other clearances for product code GTJ

  • K952791 — DIRECTIGEN MENINGITIS COMBO TEST (May 30, 1996)
  • K915330 — DIRECTIGEN MENINGITIS COMBO TEST KIT (March 23, 1992)
  • 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)