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510(k) K830869

POLYCHACO INDIRECT IMMUNOFLUORESCENCE by Parasitic Disease Consultants — Product Code GLZ

K830869 is an FDA 510(k) premarket notification submitted by Parasitic Disease Consultants for the device "POLYCHACO INDIRECT IMMUNOFLUORESCENCE". The FDA issued a decision of Substantially Equivalent on August 11, 1983. The device falls under product code GLZ (Antigens, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Parasitic Disease Consultants has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1983
Date Received
March 18, 1983
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 Parasitic Disease Consultants

  • K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION (August 12, 1983)
  • K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILIS (July 26, 1983)

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)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • 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