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510(k) K854108

POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO by Medical Diagnostic Technologies, Inc. — Product Code LHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
October 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
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Other clearances for product code LHL

  • K984123 — THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. (January 11, 1999)
  • K970149 — LEGIONELLA ELISA TEST SYSTEM (June 18, 1997)
  • K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM (March 3, 1997)
  • K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (July 28, 1992)
  • K871328 — DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT (September 2, 1987)
  • K864006 — LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST (April 20, 1987)
  • K852237 — LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (August 22, 1985)
  • K842683 — GENETIC SYS LEGIONELLA IMMUNOFLURORES (August 2, 1984)
  • K832896 — LEGIONELLA INDIRECT FLUORESCENT ANTIBOD (October 14, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)