HEMODIALYSIS BATH CONCENTRATE SOLUTION— 510(k) K842058
Substantially EquivalentPharmaceutical Development Systems
FDA 510(k) clearance K842058 for HEMODIALYSIS BATH CONCENTRATE SOLUTION, Substantially Equivalent on 1984-07-26. Applicant: Pharmaceutical Development Systems.
Clearance details
- Applicant
- Pharmaceutical Development Systems
- Product code
- Code FKQ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code FKQ
product code FKQ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.