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510(k) K023894

ST AIA-PACK AFP ENZYME IMMUNOASSAY by Tosoh Medics, Inc. — Product Code LOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2002
Date Received
November 22, 2002
Clearance Type
Special
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 Tosoh Medics, Inc.

  • K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY (December 18, 2002)
  • K023091 — ST AIA-PACK TESTOSTERONE ASSAY (December 17, 2002)
  • K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (December 6, 2002)
  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • K012820 — AIA-PACK CTNI 2ND-GEN ASSAY (December 14, 2001)
  • K011434 — G7 AUTOMATED HPLC ANALYZER (September 18, 2001)
  • K010796 — AIA-PACK BRCA, ST AIA PACK BRCA (August 16, 2001)
  • K992365 — AIA-PACK FOLATE ASSAY (August 10, 1999)
  • K990431 — AIA-PACK CA 125 (June 3, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)

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)
  • K081709 — OLYMPUS AFP - ALPHA-FETOPROTEIN (March 16, 2009)
  • K080017 — VIDAS AFP ASSAY (September 26, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • 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)