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510(k) K083724

WIENER LAB. URINE STRIP 10 AND 11 by Wiener Laboratorios Saic — Product Code JIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2009
Date Received
December 15, 2008
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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