Igg (Fab Fragment Specific), Antigen, Antiserum, Control
The IgG (Fab Fragment Specific) Antigen, Antiserum, and Control is an immunological reagent designed to specifically detect or measure the Fab fragment portion of IgG immunoglobulins in biological specimens. This product is classified as FDA Class 1, indicating it poses low risk and is subject only to general controls without requiring premarket notification. It is regulated under 21 CFR 866.5520 within the Immunology specialty. No special risk flags apply to this device.
Research product code DFK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DFK
- Device Class
- FDA class 1
- Regulation Number
- 866.5520
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
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 |
|---|---|---|---|---|
| K790711 | ANTISERA TO HUMAN FRAGMENT | Sep 04, 1979 | Substantially Equivalent | Kent Laboratories, Inc. |
| K771243 | ANTISERA TO HUMAN FAB FRAGMENT | Aug 03, 1977 | Substantially Equivalent | Kent Laboratories, Inc. |
| K770670 | FLOR. CONJUG. HUMAN FAB FRAGMENT | Apr 28, 1977 | Substantially Equivalent | Kent Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.