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510(k) K061496

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST by Sa Scientific , Ltd. — Product Code MJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2007
Date Received
May 31, 2006
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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  • K041439 — SAS INFLUENZA B TEST (July 22, 2004)
  • K030628 — SAS RSV CONTROL KIT (March 17, 2003)
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  • K023270 — SAS STREPALERT (October 17, 2002)
  • K020438 — SAS VALUE HCG (March 8, 2002)

Other clearances for product code MJH

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  • K163273 — TRU Legionella (February 21, 2017)
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  • 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)