510(k) K884725
K884725 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS". The FDA issued a decision of Substantially Equivalent on Jan 30, 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
- Jan 30, 1989
- Date Received
- Nov 10, 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)