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510(k) K063295

ACON UTI URINARY TRACT INFECTION TEST STRIPS by ACON Laboratories, Inc. — Product Code LJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2007
Date Received
November 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urine Leukocyte
Device Class
Class I
Regulation Number
864.7675
Review Panel
HE
Submission Type

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