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510(k) K090236

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 by Siemens Healthcare Diagnostics — Product Code LOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2009
Date Received
February 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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Other clearances for product code LOJ

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  • K080017 — VIDAS AFP ASSAY (September 26, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY (December 17, 2002)
  • K020807 — AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (October 1, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)
  • K983031 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (December 18, 1998)