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510(k) K081615

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN by Olympus America, Inc. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2009
Date Received
June 9, 2008
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

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  • K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (November 29, 2006)
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  • K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028 (June 6, 2006)

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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)
  • 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)