510(k) K863824

SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. by D.R.G. Scientific Industries — Product Code FKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
September 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution-Test Standard-Conductivity, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type