Home / 510(k) Clearances / K771560

510(k) K771560

TOXHA TEST by Burroughs Wellcome Co. — Product Code GMM

K771560 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "TOXHA TEST". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code GMM (Antigens, Iha, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Burroughs Wellcome Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
August 15, 1977
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 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)
  • K791231 — DAC-CEL T4 (September 4, 1979)
  • K791232 — DAC-CEL T3 (September 4, 1979)
  • K781607 — STREP-TEX (October 17, 1978)
  • K780873 — THYMUNE-M (June 14, 1978)

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)
  • K790460 — TXOCELL-IHA REAGENT SYSTEM (May 25, 1979)

FDA data resources