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510(k) K200215

ADVIA Centaur CEA Assay by Siemens Healthcare Disgnostics, Inc. — Product Code DHX

K200215 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Disgnostics, Inc. for the device "ADVIA Centaur CEA Assay". The FDA issued a decision of Substantially Equivalent on April 13, 2020. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2020
Date Received
January 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Carcinoembryonic Antigen
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances for product code DHX

  • K223921 — Access CEA (September 22, 2023)
  • K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack (August 23, 2023)
  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K080194 — VIDAS CEA (S) ASSAY (October 9, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K041322 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (June 17, 2004)
  • K031270 — ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (May 6, 2003)
  • K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY (December 18, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)
  • K991707 — MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, (June 1, 1999)

FDA data resources