Product Code: KTP
FDA class 2
21 CFR 866.5260
Complement C3b Activator Immunoassay Reagents
Immunology
The Complement C3b Activator Immunoassay Reagents are in vitro diagnostic reagents used to measure factors involved in alternative pathway complement activation, supporting evaluation of complement-mediated immune disorders. They are classified as FDA Class 2, indicating moderate risk, and require a 510(k) premarket notification demonstrating substantial equivalence prior to marketing. The product code is KTP, regulated under 21 CFR 866.5260, in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- KTP
- Device Class
- FDA class 2
- Regulation Number
- 866.5260
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K790059 | PROACTIVATOR C3, C4 AND C3 | Mar 15, 1979 | Substantially Equivalent | Icl Scientific |