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510(k) K991074

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST by Intracel Corp. — Product Code MJH

K991074 is an FDA 510(k) premarket notification submitted by Intracel Corp. for the device "BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code MJH (Legionella, Spp., Elisa), a Class II device regulated under 21 CFR 866.3300. Intracel Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
March 31, 1999
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 Intracel Corp.

  • K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (November 7, 2000)
  • K990664 — PRIMA SYSTEM - OLD, BARTELS ELISA - NEW (March 31, 1999)
  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (November 14, 1995)

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)
  • 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