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510(k) K983031

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY by Ortho-Clinical Diagnostics, Inc. — Product Code LOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1998
Date Received
August 31, 1998
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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  • 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)