Product Code: DGD
FDA class 2
21 CFR 866.5510
Igg, Ferritin, Antigen, Antiserum, Control
Immunology
The IgG Ferritin Antigen, Antiserum, and Control is a ferritin-conjugated immunological reagent used for the detection and quantification of IgG immunoglobulins in laboratory immunoassays. It is classified as FDA Class 2, indicating moderate risk with a requirement for 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. This device qualifies for third-party 510(k) review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
12
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Basic Information
- Product Code
- DGD
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | Feb 10, 1995 | Substantially Equivalent | Clinical Controls, Inc. |
| K881345 | IMX FERRITIN | May 11, 1988 | Substantially Equivalent | Abbott Laboratories |
| K830229 | ROENTGENOGRAPHY SET | Mar 09, 1983 | Substantially Equivalent | Mallinckrodt Critical Care |