FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALYSATE ADDITIVES
K Number: K842294
·
Decision Jun 28, 1984
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
2
Review Days
17
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Basic Information
- Device Name
- DIALYSATE ADDITIVES
- K Number
- K842294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dialysis Products, Inc.
- Date Received
- June 11, 1984
- Decision Date
- June 28, 1984
- 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 Dialysis Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833653 | D-LYTE | Nov 28, 1983 | Substantially Equivalent |