510(k) K871547

ULTRA-VIOLET BUN REAGENT KIT (RATE) by Biochemical Trade, Inc. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1987
Date Received
April 20, 1987
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