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510(k) K811562

TOXOPLASMOSIS TEST KIT by Immuno-Diagnostic Products, Inc. — Product Code GLZ

K811562 is an FDA 510(k) premarket notification submitted by Immuno-Diagnostic Products, Inc. for the device "TOXOPLASMOSIS TEST KIT". The FDA issued a decision of Substantially Equivalent on July 16, 1981. The device falls under product code GLZ (Antigens, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Immuno-Diagnostic Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1981
Date Received
June 3, 1981
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 Immuno-Diagnostic Products, Inc.

  • K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT (April 24, 1986)
  • K811021 — HERPES (November 5, 1981)
  • K811022 — ANA TEST KIT (April 23, 1981)
  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)

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)
  • K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS (January 29, 1981)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K791618 — TORCH BIO-BEAD SCREEN KIT (November 13, 1979)

FDA data resources