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510(k) K030600

AUTION JET AJ-4270 URINE ANALYZER by International Remote Imaging Systems — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2003
Date Received
February 25, 2003
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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