BICARB-O-MATE HEMODIALYSIS SOD. BICARB.— 510(k) K802465
Substantially EquivalentRenal Systems, Inc.
FDA 510(k) clearance K802465 for BICARB-O-MATE HEMODIALYSIS SOD. BICARB., Substantially Equivalent on 1980-11-12. Applicant: Renal Systems, Inc..
Clearance details
- Applicant
- Renal Systems, Inc.
- Product code
- Code FKR
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.