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510(k) K913467

TOXOGEN by Biokit USA, Inc. — Product Code LLA

K913467 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "TOXOGEN". The FDA issued a decision of Substantially Equivalent on January 11, 1993. The device falls under product code LLA (Direct Agglutination Test, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Biokit USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
August 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Direct Agglutination Test, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Biokit USA, Inc.

  • K910541 — BIOKIT RPR (October 18, 1991)
  • K904310 — RHEUMAGEN RF T-CONTROL (May 31, 1991)
  • K910539 — RHEUMAJET RF (April 5, 1991)
  • K910686 — RHEUMAJET CRP (March 19, 1991)
  • K904311 — RHEUMAGEN ASO T-CONTROL (January 25, 1991)
  • K904312 — RHEUMAGEN CRP T-CONTROL (October 1, 1990)
  • K896433 — MODIFIED RUBAGEN (November 29, 1989)
  • K896272 — QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (November 8, 1989)
  • K896271 — QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (November 8, 1989)
  • K894486 — QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) (October 24, 1989)

Other clearances for product code LLA

  • K890048 — QUIK-DOT TOXOPLASMOSIS (June 9, 1989)
  • K850768 — TOXOSCAN CARD TEST KIT (May 20, 1985)
  • K831930 — TOXO-SCREEN DA TEST (September 26, 1983)

FDA data resources