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510(k) K031270

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS by Beckman Coulter, Inc. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2003
Date Received
April 21, 2003
Clearance Type
Special
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

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  • 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)
  • K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY (December 18, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)
  • K990943 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUC (June 1, 1999)