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510(k) K790460

TXOCELL-IHA REAGENT SYSTEM by Calbiochem-Behring Corp. — Product Code GMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1979
Date Received
March 5, 1979
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

  • K981263 — TOXOGEN (August 6, 1998)
  • 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)
  • K771560 — TOXHA TEST (September 15, 1977)