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510(k) K772243

TOXO TEST by Gull Laboratories, Inc. — Product Code GLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1977
Date Received
December 8, 1977
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

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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)