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510(k) K990774

ABBOTT ARCHITECT CEA by Abbott Laboratories — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1999
Date Received
March 9, 1999
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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