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510(k) K821741

URICACID by Biodynamics Corp. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
June 14, 1982
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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