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510(k) K851976

HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT by Si Sero-Immuno Diagnostics, Inc. — Product Code GMM

K851976 is an FDA 510(k) premarket notification submitted by Si Sero-Immuno Diagnostics, Inc. for the device "HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code GMM (Antigens, Iha, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Si Sero-Immuno Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
May 7, 1985
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

Other clearances by Si Sero-Immuno Diagnostics, Inc.

  • K851977 — HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (October 16, 1985)

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)
  • 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)

FDA data resources