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510(k) K070522

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 by Inverness Medical Professional Diagnostics — Product Code MJH

K070522 is an FDA 510(k) premarket notification submitted by Inverness Medical Professional Diagnostics for the device "MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012". The FDA issued a decision of Substantially Equivalent on March 15, 2007. The device falls under product code MJH (Legionella, Spp., Elisa), a Class II device regulated under 21 CFR 866.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2007
Date Received
February 23, 2007
Clearance Type
Special
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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  • K113190 — TRU LEGIONELLA (February 24, 2012)
  • K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (June 28, 2007)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (December 21, 1999)
  • 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)

FDA data resources