FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALYSATE CONCENTRATE
K Number: K812330
·
Decision Sep 29, 1981
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
5
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DIALYSATE CONCENTRATE
- K Number
- K812330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Central Biological Co.
- Date Received
- August 18, 1981
- Decision Date
- September 29, 1981
- Product Code
- FKQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FKQ | System, Dialysate Delivery, Central Multiple Patient | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKQ), ordered by most recent decision date.
DIACAP ULTRA DIALYSIS FLUID FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TWO TANK DISSOLUTION MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KAWASUMI A.V. FISTULA SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACID FUCHSIN SOLUTIONS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology