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510(k) K931970

ABBOTT IMX2 ANALYER by Abbott Laboratories — Product Code JJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1993
Date Received
April 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Enzyme, For Clinical Use
Device Class
Class I
Regulation Number
862.2500
Review Panel
CH
Submission Type

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