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510(k) K791618

TORCH BIO-BEAD SCREEN KIT by Litton Bionetics — Product Code GLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
August 20, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, If, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Litton Bionetics

  • K840417 — EBNA ACIF KIT (December 27, 1984)
  • K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT (March 16, 1984)
  • K831343 — CMV RQ BIO-ENZABEAD KIT (August 8, 1983)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821804 — RUBELLA RQ BIO-ENZABEAD KIT (September 14, 1982)
  • K801721 — HSV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801722 — CMV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K791614 — HSV BIO-BEAD SCREEN KIT (November 13, 1979)

Other clearances for product code GLZ

  • K924882 — TOXOPLASMA IGM IFA TEST SYSTEM (March 23, 1993)
  • K880007 — TOXO IGM TEST (March 17, 1988)
  • K850591 — FIAX TOXO-M ANTIBODIES TEST KIT (April 30, 1985)
  • K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII (January 7, 1985)
  • K842664 — ANTI-TOXOPLASMA GONDII KIT (August 28, 1984)
  • K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (November 14, 1983)
  • K830869 — POLYCHACO INDIRECT IMMUNOFLUORESCENCE (August 11, 1983)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS (January 29, 1981)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)