510(k) K871417

COLORIMETRIC URIC ACID REAGENT SET by Biochemical Trade, Inc. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1987
Date Received
April 7, 1987
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