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510(k) K033051

LEGIONELLA PNEUMOPHILA IGG/IGM by Trinity Biotech USA — Product Code MJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legionella, Spp., Elisa
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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  • K982238 — BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELL (August 21, 1998)
  • K934965 — BINAX LEGIONELLA URINARY ANTIGEN EIA (September 20, 1994)
  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)