510(k) K993212

DRYASOL ACID CONCENTRATE MIX by Diasol, Inc. — Product Code KPO

K993212 is an FDA 510(k) premarket notification submitted by Diasol, Inc. for the device "DRYASOL ACID CONCENTRATE MIX". The FDA issued a decision of Substantially Equivalent on October 22, 1999. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Diasol, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1999
Date Received
September 24, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type