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510(k) K023764

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 by Beckman Coulter, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2003
Date Received
November 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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