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510(k) K844287

ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII by Apple Diagnostic Products — Product Code GLZ

K844287 is an FDA 510(k) premarket notification submitted by Apple Diagnostic Products for the device "ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII". The FDA issued a decision of Substantially Equivalent on January 7, 1985. The device falls under product code GLZ (Antigens, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Apple Diagnostic Products has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1985
Date Received
November 5, 1984
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 Apple Diagnostic Products

  • K843745 — ADP ANA APPLEZYME (October 25, 1984)
  • K843120 — APPLELISA CHLAMYDIA TRACHOMATIS ANTI (September 12, 1984)
  • K842707 — ADP NDNA IFA TEST (August 21, 1984)
  • K842183 — ADP ANA IFA TEST (June 22, 1984)
  • K834241 — ANA APPLELISA (April 4, 1984)
  • K834242 — ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS (March 2, 1984)

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)
  • 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)
  • K791618 — TORCH BIO-BEAD SCREEN KIT (November 13, 1979)

FDA data resources