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510(k) K911356

LEGIONELLA STAT IGG/IGM TEST KIT by Whittaker Bioproducts, Inc. — Product Code MJH

K911356 is an FDA 510(k) premarket notification submitted by Whittaker Bioproducts, Inc. for the device "LEGIONELLA STAT IGG/IGM TEST KIT". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code MJH (Legionella, Spp., Elisa), a Class II device regulated under 21 CFR 866.3300. Whittaker Bioproducts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
March 28, 1991
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 by Whittaker Bioproducts, Inc.

  • K913212 — 3M IGE SINGLE POINT FAST TEST (November 22, 1991)
  • K904652 — LYME STAT M TEST KIT (October 21, 1991)
  • K904893 — FIAX LYME M TEST KIT (October 16, 1991)
  • K911473 — EBNA STAT TEST KIT (September 25, 1991)
  • K905468 — PYLORI-G FIAX TEST KIT (May 7, 1991)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)
  • K894932 — FIAX EB VCA-M TEST KIT (October 16, 1989)
  • K894235 — EB VCA STAT M TEST KIT (August 30, 1989)

Other clearances for product code MJH

  • K191184 — ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (March 5, 2020)
  • 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)

FDA data resources