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510(k) K012260

WIENER LAB. UREA UV CINETICA AA by Wiener Laboratories Saic — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2001
Date Received
July 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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