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510(k) K111221

MISSION U500 URINE ANALYZER by ACON Laboratories, Inc. — Product Code JIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2012
Date Received
May 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood, Occult, Colorimetric, In Urine
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

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