FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇪 Ireland
RANDOX PREALBUMIN
K Number: K000661
·
Decision Apr 13, 2000
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
10
Applicant Total
116
Review Days
45
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Basic Information
- Device Name
- RANDOX PREALBUMIN
- K Number
- K000661
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5060
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- February 28, 2000
- Decision Date
- April 13, 2000
- Product Code
- JZJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZJ | Prealbumin, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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