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510(k) K944731

ABBOTT IMX 2 ANALYZER by Abbott Laboratories — Product Code JJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1994
Date Received
September 12, 1994
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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