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510(k) K023893

ST AIA-PACK CEA ENZYME IMMUNOASSAY by Tosoh Medics, Inc. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
November 22, 2002
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

Other clearances by Tosoh Medics, Inc.

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  • K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY (December 17, 2002)
  • K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (December 6, 2002)
  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • K012820 — AIA-PACK CTNI 2ND-GEN ASSAY (December 14, 2001)
  • K011434 — G7 AUTOMATED HPLC ANALYZER (September 18, 2001)
  • K010796 — AIA-PACK BRCA, ST AIA PACK BRCA (August 16, 2001)
  • K992365 — AIA-PACK FOLATE ASSAY (August 10, 1999)
  • K990431 — AIA-PACK CA 125 (June 3, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)

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  • 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)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)
  • K990943 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUC (June 1, 1999)