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510(k) K013783

AUTION MAX AX-4280 URINALYSIS SYSTEM by International Remote Imaging Systems — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2002
Date Received
November 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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