Product Code: DGJ
FDA class 1
21 CFR 866.5230
Colostrum, Antigen, Antiserum, Control
Immunology
The Colostrum Antigen, Antiserum, and Control is an immunological reagent used to detect or characterize proteins and immunoglobulins present in colostrum, the first form of milk produced by mammals. It is classified as FDA Class 1, indicating low risk, and is subject only to general manufacturing and labeling controls without requiring premarket notification. The device is regulated under 21 CFR 866.5230 within the Immunology specialty.
510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
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Basic Information
- Product Code
- DGJ
- Device Class
- FDA class 1
- Regulation Number
- 866.5230
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
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 |
|---|---|---|---|---|
| K890689 | ADX TM OPIATES | Aug 25, 1989 | Substantially Equivalent | Abbott Laboratories |