510(k) K895199

BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE by Baxter Healthcare Corp — Product Code KPO

K895199 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE". The FDA issued a decision of Substantially Equivalent on Dec 13, 1989. 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
Dec 13, 1989
Date Received
Aug 18, 1989
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 K895199. Report a data issue: hello@regdatalab.com.