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510(k) K802452

TOXOTEST-MT EIKEN KIT by Syn-Kit, Inc. — Product Code GMM

K802452 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "TOXOTEST-MT EIKEN KIT". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code GMM (Antigens, Iha, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
October 8, 1980
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 Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K861631 — SLIDE CULTURE U 'EIKEN' (June 10, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843757 — UROPAPER EIKEN AG (December 18, 1984)
  • K843753 — UROPAPER EIKEN GP (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)

Other clearances for product code GMM

  • K981263 — TOXOGEN (August 6, 1998)
  • K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (November 20, 1995)
  • K851976 — HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (October 16, 1985)
  • K851977 — HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (October 16, 1985)
  • K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION (August 12, 1983)
  • K790460 — TXOCELL-IHA REAGENT SYSTEM (May 25, 1979)
  • K771560 — TOXHA TEST (September 15, 1977)

FDA data resources