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510(k) K081709

OLYMPUS AFP - ALPHA-FETOPROTEIN by Olympus Life Science Research Europa GmbH (Europa) — Product Code LOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2009
Date Received
June 17, 2008
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

Other clearances by Olympus Life Science Research Europa GmbH (Europa)

  • K080435 — OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 (September 5, 2008)
  • K080094 — OLYMPUS TOTAL BHCG TEST SYSTEN (September 3, 2008)

Other clearances for product code LOJ

  • K220176 — Elecsys AFP (September 15, 2022)
  • K213626 — VITROS AFP (June 15, 2022)
  • K090236 — DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (April 27, 2009)
  • 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)