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510(k) K832900

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI by Bionetic Laboratory Products — Product Code GLZ

K832900 is an FDA 510(k) premarket notification submitted by Bionetic Laboratory Products for the device "IMMUNOENZYME TEST SYS-DETECT-IGM ANTI". The FDA issued a decision of Substantially Equivalent on November 14, 1983. The device falls under product code GLZ (Antigens, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Bionetic Laboratory Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
August 29, 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 Bionetic Laboratory Products

  • K833637 — VZV BIO-ENZABEAD SCREEN KIT (February 10, 1984)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)
  • K830820 — LEGIONELLA DFA KIT I (June 8, 1983)
  • K831133 — AMEBIASIS BIO-ENZABEAD SCREEN KIT (June 8, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 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)
  • 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