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510(k) K013568

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM by Bayer Corp. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2001
Date Received
October 26, 2001
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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  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K012337 — BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (December 6, 2001)

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