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510(k) K041322

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS by Ortho-Clinical Diagnostics, Inc. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2004
Date Received
May 18, 2004
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)
  • 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)
  • K990943 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUC (June 1, 1999)