FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMUCHINA/DIALYZER DISINFECTANT
K Number: K852359
·
Decision May 13, 1986
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
5
Review Days
343
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Basic Information
- Device Name
- AMUCHINA/DIALYZER DISINFECTANT
- K Number
- K852359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Amuchina Intl., Inc.
- Date Received
- June 4, 1985
- Decision Date
- May 13, 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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