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510(k) K832069

TOXO IPA KIT IAN INDIRECT FLUORESCENT by Bionetic Laboratory Products — Product Code LJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
June 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, If, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

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  • 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)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)

Other clearances for product code LJK

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  • K911771 — ARD(TM) ANTIMICROBIAL REMOVAL DEVICE (July 1, 1991)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K861460 — SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 (May 2, 1986)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)