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510(k) K070929

ACON U120 URINE ANALYZER, MODEL U111-101 by ACON Laboratories, Inc. — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
April 3, 2007
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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