FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMODIALYSIS CONCENTRATE
K Number: K854391
·
Decision Jan 8, 1986
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
2
Review Days
69
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Basic Information
- Device Name
- HEMODIALYSIS CONCENTRATE
- K Number
- K854391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dana Laboratories
- Date Received
- October 31, 1985
- Decision Date
- January 8, 1986
- 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 |
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Other Clearances by Dana Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K851431 | HEMODIALYSIS CONCENTRATE ADDITIVES | Jun 12, 1985 | Substantially Equivalent |