Home / 510(k) Clearances / K223921

510(k) K223921

Access CEA by Beckman Coulter, Inc. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
December 29, 2022
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 by Beckman Coulter, Inc.

  • K254059 — Access anti-HBc IgM (March 13, 2026)
  • K253687 — Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access (February 19, 2026)
  • K251995 — Access anti-HAV IgM (January 27, 2026)
  • K250588 — Access Rubella IgG (November 17, 2025)
  • K252580 — iQ200 Series (September 10, 2025)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m (July 18, 2025)

Other clearances for product code DHX

  • K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack (August 23, 2023)
  • K200215 — ADVIA Centaur CEA Assay (April 13, 2020)
  • 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)