FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇷 Iran
RANDOX COMPLEMENT C4
K Number: K000468
·
Decision Mar 27, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
33
Applicant Total
116
Review Days
45
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Basic Information
- Device Name
- RANDOX COMPLEMENT C4
- K Number
- K000468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- February 11, 2000
- Decision Date
- March 27, 2000
- Product Code
- DBI
- 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 |
|---|---|---|---|
| DBI | Complement C4, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
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