CITRISOL ACID CONCENTRATE

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

DIASOL, INC.

The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Citrisol Acid Concentrate.

Pre-market Notification Details

Device IDK130511
510k NumberK130511
Device Name:CITRISOL ACID CONCENTRATE
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant DIASOL, INC. 1110 Arroyo St San Fernando,  CA  91340
ContactMonica Abeles
CorrespondentMonica Abeles
DIASOL, INC. 1110 Arroyo St San Fernando,  CA  91340
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-27
Decision Date2014-02-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B467CSP4522575100 K130511 000
B467CS100125101004 K130511 000
B467CS1002251010055 K130511 000
B467CS100225751004 K130511 000
B467CS100325101004 K130511 000
B467CS100330101004 K130511 000
B467CS80225102004 K130511 000
B467CSP352251010025 K130511 000
B467CSP451257510016 K130511 000
B467CS100000101004 K130511 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.