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510(k) K981263

TOXOGEN by Instrumentation Laboratory CO — Product Code GMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1998
Date Received
April 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Iha, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

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Other clearances for product code GMM

  • K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (November 20, 1995)
  • K851977 — HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (October 16, 1985)
  • K851976 — HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (October 16, 1985)
  • K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION (August 12, 1983)
  • K802452 — TOXOTEST-MT EIKEN KIT (December 18, 1980)
  • K790460 — TXOCELL-IHA REAGENT SYSTEM (May 25, 1979)
  • K771560 — TOXHA TEST (September 15, 1977)