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510(k) K010421

WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 by Wiener Laboratories Saic — Product Code KNK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 13, 2001
Date Received: February 12, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Acid, Uric, Uricase (Colorimetric)
Device Class: Class I
Regulation Number: 862.1775
Review Panel: CH
Submission Type

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