510(k) K880102

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS by Baxter Healthcare Corp — Product Code KPO

K880102 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS". The FDA issued a decision of Substantially Equivalent on May 26, 1988. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1988
Date Received
Jan 12, 1988
Clearance Type
Traditional
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
510(k)

Source: FDA 510(k) database entry for K880102. Report a data issue: hello@regdatalab.com.