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510(k) K191184

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test by Ssi Diagnostica A/S — Product Code MJH

K191184 is an FDA 510(k) premarket notification submitted by Ssi Diagnostica A/S for the device "ImmuView S pneumoniae and L pneumophila Urinary Antigen Test". The FDA issued a decision of Substantially Equivalent on March 5, 2020. 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 5, 2020
Date Received
May 3, 2019
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

Other clearances for product code MJH

  • K163273 — TRU Legionella (February 21, 2017)
  • K113190 — TRU LEGIONELLA (February 24, 2012)
  • K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (June 28, 2007)
  • K070522 — MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 (March 15, 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